ticlopidine and Coronary Occlusion

ticlopidine has been researched along with Coronary Occlusion in 14 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.

Coronary Occlusion: Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.

Research

Studies (14)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)

Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population) (NCT01156571)
Timeframe: 48 hours after randomization

Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild

GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial (NCT01156571)
Timeframe: 48 hours after randomization

Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)

CEC-adjudicated results (mITT population) (NCT01156571)
Timeframe: 48 hours after randomization

Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI

(a patient could have multiple procedural events) (NCT00305162)
Timeframe: during index PCI

Incidence of ACUITY Major Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)

excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Incidence of All Cause Mortality

(excluding STEMI) (NCT00305162)
Timeframe: randomization through 1 year after randomization

Incidence of All-cause Mortality

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Incidence of All-cause Mortality and MI

(composite incidence) (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Incidence of All-cause Mortality or MI

(composite incidence) (NCT00305162)
Timeframe: randomization through 30 days after randomization

Incidence of All-cause Mortality, MI or IDR

(composite incidence) (NCT00305162)
Timeframe: randomization through 30 days after randomization

Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)

(composite incidence) (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Incidence of GUSTO Severe / Life-threatening Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Incidence of IDR

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Incidence of MI

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Incidence of Stroke

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Individual Incidence of All-cause Mortality

(NCT00305162)
Timeframe: randomization through 48 hours after randomization

Individual Incidence of IDR

(NCT00305162)
Timeframe: randomization through 48 hours after randomization

Incidence of Stroke

"Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:~primary hemorrhagic - stroke with focal collections of intracranial blood~ischemic cerebral infarction - stroke without focal collections of intracranial blood~infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding~uncertain - no imaging or autopsy data are available." (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Incidence of ACUITY Major Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm

Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm. (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of All-cause Mortality

mITT population (NCT00385138)
Timeframe: randomization through 1 year post randomization

Incidence of All-cause Mortality

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Incidence of All-cause Mortality

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of All-cause Mortality or MI

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Incidence of All-cause Mortality or MI

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of All-cause Mortality, MI, or IDR

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)

mITT population; (composite incidence) (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of GUSTO Severe / Life-threatening

Major bleeding (non-CABG-related) - Safety population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of IDR

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Incidence of IDR

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of MI

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Incidence of MI

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]

mITT population A patient could have multiple procedural events. (NCT00385138)
Timeframe: During index PCI

Incidence of Stent Thrombosis

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Incidence of Stent Thrombosis

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of Stroke

mITT (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Incidence of Stroke

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major

Major bleeding (non-CABG-related) - Safety population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Device Time

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)

Fluoroscopy Duration

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)

Number of Participants With Acute Procedural Success Rate

Defined as successful MitraClip implantation with resulting MR of 2+ or less. (NCT01301625)
Timeframe: At day 0 (on the day of index procedure)

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

"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

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

"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

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

"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

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

"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

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

"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

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

"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

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

"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

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

"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

Post-procedure Hospital Stay

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

Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration

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

Procedure Time

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)

Six Minute Walking Distance

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

Six Minute Walking Distance

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

Six Minute Walking Distance

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

Six Minute Walking Distance

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

Total Contrast Volume

This is one of the Device and Procedure-Related Endpoints. (NCT01301625)
Timeframe: At day 0 (on the day of index procedure)

Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months

"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

Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days

"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

Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months

"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

Duration of Rehospitalization

(NCT01301625)
Timeframe: 30 days

Left Atrial Volume

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

Left Atrial Volume

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

Left Atrial Volume

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)

Left Ventricle End Diastolic Volume (LVEDV)

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

Left Ventricle End Diastolic Volume (LVEDV)

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

Left Ventricle End Diastolic Volume (LVEDV)

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)

Left Ventricular Ejection Fraction (LVEF)

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

Left Ventricular Ejection Fraction (LVEF)

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

Left Ventricular Ejection Fraction (LVEF)

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)

Left Ventricular End Systolic Volume (LVESV)

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

Left Ventricular End Systolic Volume (LVESV)

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

Left Ventricular End Systolic Volume (LVESV)

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)

Left Ventricular Internal Diameter End Diastole (LVIDd)

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

Left Ventricular Internal Diameter End Diastole (LVIDd)

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

Left Ventricular Internal Diameter End Diastole (LVIDd)

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)

Left Ventricular Internal Diameter End Systole (LVIDs)

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

Left Ventricular Internal Diameter End Systole (LVIDs)

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

Left Ventricular Internal Diameter End Systole (LVIDs)

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)

Mitral Valve Area (MVA) by Pressure Half-time (PHT)

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

Mitral Valve Area (MVA) by Pressure Half-time (PHT)

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

Mitral Valve Area (MVA) by Pressure Half-time (PHT)

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)

Mitral Valve Mean Gradient

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

Mitral Valve Mean Gradient

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

Mitral Valve Mean Gradient

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)

Number of Participants at Discharge Facility

This is the economic data reported to support the MitraClip System economic analysis. (NCT01301625)
Timeframe: < or = 12 days

Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted

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)

Number of Participants With Mitral Valve Surgery

Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair. (NCT01301625)
Timeframe: 30 days of Post-MitraClip Procedure

Number of Participants With MR Severity

"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

Number of Participants With MR Severity

"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

Number of Participants With MR Severity

"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

Number of Participants With MR Severity

"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)

Number of Participants With MR Severity

"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

Number of Participants With Second Intervention to Place an Additional MitraClip Device

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

Percentage of Participants With New York Heart Association (NYHA) Class

"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

Percentage of Participants With New York Heart Association (NYHA) Class

"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

Percentage of Participants With New York Heart Association (NYHA) Class

"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

Percentage of Participants With New York Heart Association (NYHA) Class

"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

Rate of Patients Rehospitalized

Defined as re-admission of patients to the hospital following discharge from the Clip procedure. (NCT01301625)
Timeframe: 30 days

Regurgitant Fraction

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

Regurgitant Fraction

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

Regurgitant Fraction

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)

Regurgitant Volume

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

Regurgitant Volume

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

Regurgitant Volume

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)

Reviews

2 reviews available for ticlopidine and Coronary Occlusion

Trials

2 trials available for ticlopidine and Coronary Occlusion

Other Studies

10 other studies available for ticlopidine and Coronary Occlusion