Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

Abbott Medical Devices776 enrolled

Overview

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation. Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017. As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints) As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated Study Completion Date is July 2024. COAPT CAS completed recruiting subjects in March 2019.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). As part of the COAPT trial, a subset of patients (at least 50 up to 100 in total) will be registered in the CPX Sub-study, which is designed as a prospective, randomized (1:1 ratio to the MitraClip or no MitraClip device), parallel-controlled, multicenter study registering approximately 50-100 subjects in up to 50 qualified US sites from the COAPT trial. Subjects registered and randomized in the CPX Sub-study will contribute to the total enrollment approximately of 610 subjects in the COAPT trial. Roll-in subjects will not participate in the CPX Sub-study. The COAPT CAS study is designed as a prospective, multicenter, single arm, continued access registry study. A maximum of 800 subjects (anticipated) will be registered from up to 75 sites in the United States. The enrollment will end once pre-market approval (PMA) of the proposed expanded indication of MitraClip System is obtained. Active follow-up of patients will be performed through 12 months with scheduled visits at 30 days and 12 months. The national Trans catheter Valve Therapy Registry (TVT Registry) will be used for data collection through 12 months. Annual follow-up data from 2 years through year 5 post-implant will be obtained by linkage to the Centers for Medicare and Medicaid Services (CMS) Claims database. COAPT CAS data may be used to support the PMA application of the labeling claims for the treatment of moderate to severe or severe FMR in symptomatic heart failure subjects. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. A total of 162 subjects were enrolled in the COAPT CAS Group.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology. Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present. Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from \<92% to ≥92%) 2. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or GDMT). The Eligibility Committee must also concur that the subject has been adequately treated. 3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. 4. The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group. 5. The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2). Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on GDMT and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from \<92% to ≥92%). 6. Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment). 7. The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant. 8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days \< local laboratory Upper Limit of Normal (ULN). 9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator. 10. Age 18 years or older. 11. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial. 12. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent. 13. Left Ventricular End Systolic Dimension (LVESD) is ≤ 70 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration. For the CPX Sub-study: Subjects have to meet the COAPT study eligibility criteria to be registered in the CPX Sub-study. COAPT CAS study Inclusion Criteria: 1\. Subjects must meet all of the above COAPT RCT inclusion criteria, and must have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS). Exclusion Criteria: 1. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use. 2. Untreated clinically significant coronary artery disease requiring revascularization. 3. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration. 4. Percutaneous coronary intervention within 30 days prior to subject registration. 5. Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration. 6. Tricuspid valve disease requiring surgery or transcatheter intervention. 7. Aortic valve disease requiring surgery. 8. Cerebrovascular accident within 30 days prior to subject registration. 9. Severe symptomatic carotid stenosis (\> 70% by ultrasound). 10. Carotid surgery or stenting within 30 days prior to subject registration. 11. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure. 12. Presence of any of the following: * Estimated pulmonary artery systolic pressure (PASP) \> 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to \< 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology * Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) * Hemodynamic instability requiring inotropic support or mechanical heart assistance. 13. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site. 14. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration. 15. Mitral valve orifice area \< 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration. 16. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes: * Insufficient mobile leaflet available for grasping with the MitraClip device * Evidence of calcification in the grasping area * Presence of a significant cleft in the grasping area * Lack of both primary and secondary chordal support in the grasping area * Leaflet mobility length \< 1 cm 17. Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. 19. Life expectancy \< 12 months due to non-cardiac conditions. 20. Modified Rankin Scale ≥ 4 disability. 21. Status 1 heart transplant or prior orthotopic heart transplantation. 22. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure. 23. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 24. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated). 25. Active infections requiring current antibiotic therapy. 26. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk. 27. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically. 28. Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release. 29. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 30. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. For the CPX Sub-study: Subjects who have any contraindications to CPX and are not capable of performing CPX per investigator's assessment should not be registered in the CPX Sub-study. COAPT CAS study Exclusion Criteria: 1\. Subjects must not meet any of the above COAPT RCT exclusion criteria. .

Outcomes

Primary Outcomes

Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months

Percentage of Participants with Freedom from Device related Complications at 12 Months. Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.

Time frame: 12 months

Primary Effectiveness Endpoint

Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up

Time frame: 24 months

Secondary Outcomes

Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

Number of recurrent Heart Failure hospitalization events at 12 months.

Time frame: 12 months

New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)

The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

Time frame: 12 months

New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)

Time frame: 30 days

Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physicalfunction, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possiblesubscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies thefollowing six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical FunctionDomain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQSymptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Scoreincludes total symptom and physical function scores to correspond with NYHA Classification. Overall SummaryScore includes the total symptom, physical function, social limitations and quality of life scores.

Time frame: 12 months

Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Time frame: 30 days

Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)

The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exerciseequipment or advanced training for technicians. This test measures the distance that a patient can quickly walk ona flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of allthe systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation,peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific informationon the function of each of the different organs and systems involved in exercise or the mechanism of exerciselimitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses thesubmaximal level of functional capacity.

Time frame: 12 months

Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)

The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Time frame: 30 days

Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2

Time frame: 12 months

Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2

Time frame: 30 days

Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)

Time frame: 12 months

Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)

Time frame: 30 days

Major Vascular Complications (COAPT CAS Study Analysis)

Time frame: 12 months

Major Vascular Complications (COAPT CAS Study Analysis)

Time frame: 30 days

Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)

Time frame: 12 months

Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)

Time frame: 30 days

Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)

Time frame: 12 months

Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)

Time frame: 30 days

Stroke (COAPT CAS Study Analysis)

Time frame: 12 months

Stroke (COAPT CAS Study Analysis)

Time frame: 30 days

Myocardial Infarction (MI) (COAPT CAS Study Analysis)

Time frame: 12 months

Myocardial Infarction (MI) (COAPT CAS Study Analysis)

Time frame: 30 days

Death and Primary Cause of Death (COAPT CAS Study Analysis)

Time frame: 12 months

Death and Primary Cause of Death (COAPT CAS Study Analysis)

Time frame: 30 days

Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group

The percentage of patients free from the composite endpoint as described above.

Time frame: 30 days post-procedure in the Device group

Number of Deaths at 12 Months (All Cause Mortality)

Death from any cause mortality at 12months.

Time frame: 12 months

Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months

MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2

Time frame: 12 months

Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Time frame: 12 months over baseline

Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Time frame: 12 months over baseline

Change in Left Ventricular End Diastolic Volume (LVEDV)

Paired data comparing the Change in LVEDV at baseline vs 12 months

Time frame: 12 months over baseline

Number of Participants With New York Heart Association (NYHA) Functional Class I/II

NEW YORK HEART ASSOCIATION CLASSIFICATION (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. Patients 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.

Time frame: 12 months

Recurrent Hospitalizations - All Cause

Number of Recurrent Hospitalizations for any cause within 24 months.

Time frame: 24 Months

Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months)

The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios: A. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of "Winners" in the Device group was NW = NB + ND while the number of "Losers" in the Device group was NL = NA + NC. The "Win Ratio" was then calculated as NW/NL.

Time frame: 24 months

Death and Primary Cause of Death (COAPT CAS Study Analysis)

The COAPT study is still on-going. Only the Primary and major secondary endpoints have been entered. Rest of the results will be entered when the study ends in July 2024.

Time frame: 2 years

Death and Primary Cause of Death (COAPT CAS Study Analysis)

Time frame: 3 years

Death and Primary Cause of Death (COAPT CAS Study Analysis)

Time frame: 4 years

Death and Primary Cause of Death (COAPT CAS Study Analysis)

Time frame: 5 years

Myocardial Infarction (MI) (COAPT CAS Study Analysis)

Time frame: 2 years

Myocardial Infarction (MI) (COAPT CAS Study Analysis)

Time frame: 3 years

Myocardial Infarction (MI) (COAPT CAS Study Analysis)

Time frame: 4 years

Myocardial Infarction (MI) (COAPT CAS Study Analysis)

Time frame: 5 years

Stroke (COAPT CAS Study Analysis)

Time frame: 2 years

Stroke (COAPT CAS Study Analysis)

Time frame: 3 years

Stroke (COAPT CAS Study Analysis)

Time frame: 4 years

Stroke (COAPT CAS Study Analysis)

Time frame: 5 years

Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

Time frame: 2 years

Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

Time frame: 3 years

Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

Time frame: 4 years

Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)

Time frame: 5 years

Kaplan-Meier Freedom From All-cause Mortality

Death from any cause within 24 months - no of events

Time frame: 24 months

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

Overview

Conditions

Interventions

Eligibility

Locations (86)

Outcomes

Primary Outcomes

Secondary Outcomes