ticlopidine has been researched along with Foramen Ovale, Patent in 12 studies
Ticlopidine: An effective inhibitor of platelet aggregation commonly used in the placement of STENTS in CORONARY ARTERIES.
ticlopidine : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group.
Foramen Ovale, Patent: A condition in which the FORAMEN OVALE in the ATRIAL SEPTUM fails to close shortly after birth. This results in abnormal communications between the two upper chambers of the heart. An isolated patent ovale foramen without other structural heart defects is usually of no hemodynamic significance.
| Excerpt | Relevance | Reference |
|---|---|---|
| "A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events." | 2.77 | Closure or medical therapy for cryptogenic stroke with patent foramen ovale. ( Adams, H; Albers, GW; Felberg, R; Furlan, AJ; Herrmann, H; Kar, S; Landzberg, M; Massaro, J; Mauri, L; Raizner, A; Reisman, M; Wechsler, L, 2012) |
| "To present the case of a man with branch retinal artery occlusion (BRAO) and concomitant patent foramen ovale (PFO), which was first diagnosed during the evaluation of BRAO." | 1.42 | Undiagnosed patent foramen ovale as a rare cause for branch retinal artery occlusion. ( Chatziralli, IP; Mitropoulos, PG; Parikakis, EA, 2015) |
| "Moreover only 1 case of spinal cord infarction was attributed to paradoxical embolism through PFO, but in the anterior spinal artery territory." | 1.36 | Posterior spinal artery infarct due to patent foramen ovale: a case report. ( Federico, F; Fraddosio, A; Giorelli, M; Lucivero, V; Petruzzellis, M; Prontera, M; Tinelli, A, 2010) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 1 (8.33) | 29.6817 |
| 2010's | 11 (91.67) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Spencer, BT | 1 |
| Qureshi, Y | 1 |
| Sommer, RJ | 1 |
| Chatziralli, IP | 1 |
| Parikakis, EA | 1 |
| Mitropoulos, PG | 1 |
| Polzin, A | 1 |
| Dannenberg, L | 1 |
| Sophia Popp, V | 1 |
| Kelm, M | 1 |
| Zeus, T | 1 |
| Krizanic, F | 1 |
| Sievert, H | 1 |
| Pfeiffer, D | 1 |
| Konorza, T | 1 |
| Ferrari, M | 1 |
| Figulla, HR | 1 |
| Petruzzellis, M | 1 |
| Fraddosio, A | 1 |
| Giorelli, M | 1 |
| Prontera, M | 1 |
| Tinelli, A | 1 |
| Lucivero, V | 1 |
| Federico, F | 1 |
| Scacciatella, P | 1 |
| Butera, G | 1 |
| Amato, G | 1 |
| Tomassini, F | 1 |
| Giorgi, M | 1 |
| Marra, S | 1 |
| Dixon, SR | 1 |
| Grines, CL | 1 |
| O'Neill, WW | 1 |
| Fischer, D | 1 |
| Haentjes, J | 1 |
| Klein, G | 1 |
| Schieffer, B | 1 |
| Drexler, H | 1 |
| Meyer, GP | 1 |
| Schaefer, A | 1 |
| Easton, JD | 1 |
| Mono, ML | 1 |
| Geister, L | 1 |
| Galimanis, A | 1 |
| Jung, S | 1 |
| Praz, F | 1 |
| Arnold, M | 1 |
| Fischer, U | 1 |
| Wolff, S | 1 |
| Findling, O | 1 |
| Windecker, S | 1 |
| Wahl, A | 1 |
| Meier, B | 1 |
| Mattle, HP | 1 |
| Nedeltchev, K | 1 |
| Kalinczuk, L | 1 |
| Lubiszewska, B | 1 |
| Demkow, M | 1 |
| Furlan, AJ | 1 |
| Reisman, M | 1 |
| Massaro, J | 1 |
| Mauri, L | 1 |
| Adams, H | 1 |
| Albers, GW | 1 |
| Felberg, R | 1 |
| Herrmann, H | 1 |
| Kar, S | 1 |
| Landzberg, M | 1 |
| Raizner, A | 1 |
| Wechsler, L | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand[NCT01301625] | 78 participants (Actual) | Observational | 2011-11-30 | Terminated (stopped due to As recruitment rate was lower than anticipated) | |||
| A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism [NCT00201461] | Phase 2/Phase 3 | 900 participants (Anticipated) | Interventional | 2003-06-30 | Active, not recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
This is one of the Device and Procedure-Related Endpoints. Device Time is defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter. Device Time is shorter in duration than Procedure Time because it does not include the time required to perform transseptal access into the left atrium. (NCT01301625)
Timeframe: At day 0 (on the day of index procedure)
| Intervention | Minutes (Mean) |
|---|---|
| MitraClip Implant | 91.2 |
This is one of the Device and Procedure-Related Endpoints. Mean fluoroscopy duration during the MitraClip procedure. (NCT01301625)
Timeframe: At day 0 (on the day of index procedure)
| Intervention | Minutes (Mean) |
|---|---|
| MitraClip Implant | 41.2 |
Defined as successful MitraClip implantation with resulting MR of 2+ or less. (NCT01301625)
Timeframe: At day 0 (on the day of index procedure)
| Intervention | Participants (Count of Participants) |
|---|---|
| MitraClip Implant | 39 |
"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)." (NCT01301625)
Timeframe: 12 months
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 8.3 |
"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)." (NCT01301625)
Timeframe: 30 days
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 0.0 |
"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)." (NCT01301625)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 6.1 |
"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)." (NCT01301625)
Timeframe: Baseline
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 0.0 |
"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary." (NCT01301625)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 91.5 |
"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary." (NCT01301625)
Timeframe: 12 months
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 85.3 |
"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary." (NCT01301625)
Timeframe: 30 days
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 96.1 |
"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary." (NCT01301625)
Timeframe: Baseline
| Intervention | percentage of participants (Number) |
|---|---|
| MitraClip Implant | 100 |
This is the Economic data reported to support the MitraClip System economic analysis. It is defined as the mean duration of time that patients spent in hospital following the MitraClip procedure. (NCT01301625)
Timeframe: Post index procedure within 30 days
| Intervention | Days (Mean) |
|---|---|
| MitraClip Implant | 3.4 |
ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. (NCT01301625)
Timeframe: Post index procedure within 30 days
| Intervention | Hours (Mean) |
|---|---|
| MitraClip Implant | 62.1 |
This is one of the Device and Procedure-Related Endpoints. Procedure Time is defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed. (NCT01301625)
Timeframe: At day 0 (on the day of index procedure)
| Intervention | Minutes (Mean) |
|---|---|
| MitraClip Implant | 133.5 |
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity. (NCT01301625)
Timeframe: 12 months
| Intervention | Meters (Mean) |
|---|---|
| MitraClip Implant | 329.9 |
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity. (NCT01301625)
Timeframe: 30 days
| Intervention | Meters (Mean) |
|---|---|
| MitraClip Implant | 297.3 |
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity. (NCT01301625)
Timeframe: 6 months
| Intervention | Meters (Mean) |
|---|---|
| MitraClip Implant | 324.3 |
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity. (NCT01301625)
Timeframe: Baseline
| Intervention | Meters (Mean) |
|---|---|
| MitraClip Implant | 271.0 |
This is one of the Device and Procedure-Related Endpoints. (NCT01301625)
Timeframe: At day 0 (on the day of index procedure)
| Intervention | Milliliters (Mean) |
|---|---|
| MitraClip Implant | 10.6 |
"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)." (NCT01301625)
Timeframe: 12 months
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline | 12 months | Difference (12 months - Baseline) | |
| MitraClip Implant | 51.1 | 30.2 | -20.9 |
"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)." (NCT01301625)
Timeframe: 30 days
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline | 30 days | Difference (30 days - Baseline) | |
| MitraClip Implant | 50.4 | 26.4 | -24.0 |
"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)." (NCT01301625)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline | 6 months | Difference (6 months - Baseline) | |
| MitraClip Implant | 49.5 | 28.0 | -21.5 |
(NCT01301625)
Timeframe: 30 days
| Intervention | Days (Mean) | |||
|---|---|---|---|---|
| All re-hospitalizations | Heart Failure-related re-hospitalizations | Other cardiac-related re-hospitalizations | Other non-cardiac-related re-hospitalizations | |
| MitraClip Implant | 8.4 | 18.38 | 2.87 | 7.44 |
Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole. (NCT01301625)
Timeframe: At Baseline and 12 Months
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 148.5 | 132.4 |
Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 140.4 | 138.8 |
Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 141.7 | 141.8 |
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. (NCT01301625)
Timeframe: At Baseline and 12 months
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 161.1 | 150.1 |
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 152.9 | 148.2 |
Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | Milliliters (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 158.2 | 151.3 |
Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks). (NCT01301625)
Timeframe: At Baseline and 12 months
| Intervention | percent (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 46.9 | 47.4 |
Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks). (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | percent (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 48.4 | 46.5 |
Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks). (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | percent (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 47.2 | 44.6 |
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. (NCT01301625)
Timeframe: At Baseline and 12 months
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 97.8 | 91.7 |
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 88.5 | 89.0 |
Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | Milliliter (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 93.3 | 93.2 |
LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and 12 Months
| Intervention | cm (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 6.0 | 5.7 |
LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | cm (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 5.9 | 5.7 |
LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | cm (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 5.9 | 5.7 |
LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and 12 Months
| Intervention | cm (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 4.6 | 4.5 |
LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | cm (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 4.5 | 4.5 |
LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | cm (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 4.5 | 4.4 |
Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and 12 Months
| Intervention | cm^2 (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 3.8 | 2.3 |
Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | cm^2 (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 3.5 | 2.3 |
Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | cm^2 (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 3.5 | 2.4 |
Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography. (NCT01301625)
Timeframe: At Baseline and 12 Months
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 2.3 | 3.4 |
Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 2.3 | 3.5 |
Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | mmHg (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 2.3 | 3.7 |
This is the economic data reported to support the MitraClip System economic analysis. (NCT01301625)
Timeframe: < or = 12 days
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Home | Home with home health care | Skilled nursing facility | Nursing home | Death | Other | |
| MitraClip Implant | 70 | 4 | 1 | 0 | 2 | 1 |
This is one of the Device and Procedure-Related Endpoints. Implant Rate is defined as the rate of successful delivery and deployment of MitraClip device implant(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter. (NCT01301625)
Timeframe: Day 0 (On the day of procedure)
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| 0 Mitra Clip devices | 1 Mitra Clip devices | 2 Mitra Clip devices | 3 Mitra Clip devices | |
| MitraClip Implant | 1 | 41 | 35 | 1 |
Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair. (NCT01301625)
Timeframe: 30 days of Post-MitraClip Procedure
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Recurring mitral regurgitation | Device failure | |
| MitraClip Implant | 1 | 1 |
"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe." (NCT01301625)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| 0: None | 1+:Mild | 2+: Moderate | 3+: Moderate-to-Severe | 4+: Severe | Not Evaluable | |
| MitraClip Implant | 2 | 15 | 15 | 7 | 3 | 0 |
"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe." (NCT01301625)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| 0: None | 1+:Mild | 2+: Moderate | 3+: Moderate-to-Severe | 4+: Severe | Not Evaluable | |
| MitraClip Implant | 1 | 26 | 25 | 12 | 5 | 0 |
"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe." (NCT01301625)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| 0: None | 1+:Mild | 2+: Moderate | 3+: Moderate-to-Severe | 4+: Severe | Not Evaluable | |
| MitraClip Implant | 0 | 20 | 24 | 12 | 4 | 0 |
"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe." (NCT01301625)
Timeframe: At discharge (≤7 days of index procedure)
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| 0: None | 1+:Mild | 2+: Moderate | 3+: Moderate-to-Severe | 4+: Severe | Not Evaluable | |
| MitraClip Implant | 1 | 38 | 22 | 9 | 3 | 1 |
"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe." (NCT01301625)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| 0: None | 1+:Mild | 2+: Moderate | 3+: Moderate-to-Severe | 4+: Severe | Not Evaluable | |
| MitraClip Implant | 0 | 0 | 0 | 22 | 55 | 0 |
Second MitraClip device interventions are reported by Abbott Vascular personnel on Procedural Observation Forms. A second MitraClip device intervention is a good option for patients with MR following placement of the original MitraClip device. (NCT01301625)
Timeframe: Through 12 months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Recurring mitral regurgitation | Single leaflet device attachment (SLDA) | |
| MitraClip Implant | 2 | 1 |
"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased." (NCT01301625)
Timeframe: 12 months
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| NYHA I | NYHA II | NYHA III | NYHA IV | |
| MitraClip Implant | 52.5 | 42.5 | 2.5 | 2.5 |
"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased." (NCT01301625)
Timeframe: 30 days
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| NYHA I | NYHA II | NYHA III | NYHA IV | |
| MitraClip Implant | 36.2 | 44.9 | 15.9 | 2.9 |
"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased." (NCT01301625)
Timeframe: 6 months
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| NYHA I | NYHA II | NYHA III | NYHA IV | |
| MitraClip Implant | 33.3 | 56.7 | 8.3 | 1.7 |
"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased." (NCT01301625)
Timeframe: Baseline
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| NYHA I | NYHA II | NYHA III | NYHA IV | |
| MitraClip Implant | 2.6 | 26.9 | 51.3 | 19.2 |
Defined as re-admission of patients to the hospital following discharge from the Clip procedure. (NCT01301625)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| All re-hospitalizations | Heart Failure-related re-hospitalizations | Other cardiac-related re-hospitalizations | Other non-cardiac-related re-hospitalizations | |
| MitraClip Implant | 35 | 10 | 11 | 22 |
Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve. (NCT01301625)
Timeframe: At Baseline and 12 Months
| Intervention | Percentage (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 44.6 | 36.8 |
Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | Percentage (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 40.5 | 15.2 |
Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | Percentage (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 38.9 | 25.8 |
Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume. (NCT01301625)
Timeframe: At Baseline and 12 Months
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 12 Months | |
| MitraClip Implant | 49.8 | 73.3 |
Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume. (NCT01301625)
Timeframe: At Baseline and 30 Days
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | 30 Days | |
| MitraClip Implant | 61.9 | 25.6 |
Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume. (NCT01301625)
Timeframe: At Baseline and Discharge (≤7 days of index procedure)
| Intervention | ml (Mean) | |
|---|---|---|
| Baseline | Discharge | |
| MitraClip Implant | 55.5 | 25.1 |
3 reviews available for ticlopidine and Foramen Ovale, Patent
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Economy class syndrome complicated by stroke: a rare condition due to paradoxical embolism--a case report and review of the literature.
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The year in interventional cardiology.
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Antithrombotic management for transient ischemic attack and ischemic stroke (other than atrial fibrillation).
Topics: Adenosine; Aryl Hydrocarbon Hydroxylases; Brain Ischemia; Cilostazol; Clinical Trials as Topic; Clop | 2011 |
3 trials available for ticlopidine and Foramen Ovale, Patent
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A retrospective review of clopidogrel as primary therapy for migraineurs with right to left shunt lesions.
Topics: Adolescent; Adult; Clopidogrel; Female; Foramen Ovale, Patent; Humans; Middle Aged; Migraine with Au | 2014 |
Clinical evaluation of a novel occluder device (Occlutech) for percutaneous transcatheter closure of patent foramen ovale (PFO).
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Aspirin; Balloon Occlusion; Cardiac Catheterizat | 2008 |
Closure or medical therapy for cryptogenic stroke with patent foramen ovale.
Topics: Adolescent; Adult; Anticoagulants; Aspirin; Clopidogrel; Combined Modality Therapy; Drug Therapy, Co | 2012 |
6 other studies available for ticlopidine and Foramen Ovale, Patent
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Undiagnosed patent foramen ovale as a rare cause for branch retinal artery occlusion.
Topics: Adult; Clopidogrel; Echocardiography, Transesophageal; Fluorescein Angiography; Foramen Ovale, Paten | 2015 |
Antiplatelet effects of clopidogrel and aspirin after interventional patent foramen ovale/ atrium septum defect closure.
Topics: Adult; Aged; Aspirin; Blood Platelets; Cardiac Surgical Procedures; Clopidogrel; Comorbidity; Female | 2016 |
Posterior spinal artery infarct due to patent foramen ovale: a case report.
Topics: Disease-Free Survival; Female; Foramen Ovale, Patent; Humans; Infarction; Magnetic Resonance Imaging | 2010 |
Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism: procedural and follow-up results after implantation of the Amplatzer®-occluder device.
Topics: Aspirin; Cardiac Catheterization; Clopidogrel; Echocardiography, Transesophageal; Embolism, Paradoxi | 2011 |
Patent foramen ovale may be causal for the first stroke but unrelated to subsequent ischemic events.
Topics: Adult; Aged; Aspirin; Brain Ischemia; Clopidogrel; Female; Follow-Up Studies; Foramen Ovale, Patent; | 2011 |
Normal chest radiograph and ground glass opacities on a thoracic computed tomographic scan in a patient with diffuse alveolar haemorrhage due to dual antiplatelet therapy prescribed after patent foramen ovale percutaneous device closure.
Topics: Adult; Aspirin; Clopidogrel; Drug Therapy, Combination; Female; Foramen Ovale, Patent; Hemoptysis; H | 2011 |