Clinical trial NCT01626079: Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
Official title: A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects (COAPT Recruitment Closed). COAPT CAS (Recruitment Closed)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Regurgitation
Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects
Heart Failure
Keywords: Functional Mitral Regurgitation
Mitral Valve Regurgitation
Symptomatic Heart Failure
Functional MR
MitraClip
Mitral Valve Insufficiency
Cardiopulmonary exercise testing
COAPT CAS
COAPT Continued Access Study
MitraClip NT
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 criteria: 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.

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Primary outcomes:
measure: Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months
timeFrame: 12 months
measure: Primary Effectiveness Endpoint
timeFrame: 24 months
Secondary outcomes:
measure: Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 12 months
measure: Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 days
measure: Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Major Vascular Complications (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Major Vascular Complications (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Stroke (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Stroke (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Myocardial Infarction (MI) (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Myocardial Infarction (MI) (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: Death and Primary Cause of Death (COAPT CAS Study Analysis)
timeFrame: 12 months
measure: Death and Primary Cause of Death (COAPT CAS Study Analysis)
timeFrame: 30 days
measure: 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
timeFrame: 30 days post-procedure in the Device group
measure: Number of Deaths at 12 Months (All Cause Mortality)
timeFrame: 12 months
measure: Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months
timeFrame: 12 months
measure: Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)
timeFrame: 12 months over baseline
measure: Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 12 months over baseline
measure: Change in Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 12 months over baseline
measure: Number of Participants With New York Heart Association (NYHA) Functional Class I/II
timeFrame: 12 months
measure: Recurrent Hospitalizations - All Cause
timeFrame: 24 Months
measure: Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months)
timeFrame: 24 months
measure: Death and Primary Cause of Death (COAPT CAS Study Analysis)
timeFrame: 2 years
measure: Death and Primary Cause of Death (COAPT CAS Study Analysis)
timeFrame: 3 years
measure: Death and Primary Cause of Death (COAPT CAS Study Analysis)
timeFrame: 4 years
measure: Death and Primary Cause of Death (COAPT CAS Study Analysis)
timeFrame: 5 years
measure: Myocardial Infarction (MI) (COAPT CAS Study Analysis)
timeFrame: 2 years
measure: Myocardial Infarction (MI) (COAPT CAS Study Analysis)
timeFrame: 3 years
measure: Myocardial Infarction (MI) (COAPT CAS Study Analysis)
timeFrame: 4 years
measure: Myocardial Infarction (MI) (COAPT CAS Study Analysis)
timeFrame: 5 years
measure: Stroke (COAPT CAS Study Analysis)
timeFrame: 2 years
measure: Stroke (COAPT CAS Study Analysis)
timeFrame: 3 years
measure: Stroke (COAPT CAS Study Analysis)
timeFrame: 4 years
measure: Stroke (COAPT CAS Study Analysis)
timeFrame: 5 years
measure: Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
timeFrame: 2 years
measure: Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
timeFrame: 3 years
measure: Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
timeFrame: 4 years
measure: Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
timeFrame: 5 years
measure: Kaplan-Meier Freedom From All-cause Mortality
timeFrame: 24 months
Other outcomes:
measure: Device or Procedure-Related Adverse Events
timeFrame: Within and after 30 days of the procedure
measure: Implant Rate
timeFrame: Day 0
measure: Device Procedure Time
timeFrame: Day 0
measure: Total Procedure Time
timeFrame: Day 0
measure: Device Time
timeFrame: Day 0
measure: Fluoroscopy Duration
timeFrame: Day 0
measure: MR Severity Grade
timeFrame: Baseline
measure: MR Severity Grade
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: MR Severity Grade
timeFrame: 6 months
measure: MR Severity Grade
timeFrame: 12 months
measure: MR Severity Grade
timeFrame: 24 months
measure: MR Severity Grade
timeFrame: 3 years
measure: MR Severity Grade
timeFrame: 4 years
measure: MR Severity Grade
timeFrame: 5 years
measure: Effective Regurgitant Orifice Area
timeFrame: Baseline
measure: Effective Regurgitant Orifice Area
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Effective Regurgitant Orifice Area
timeFrame: 6 months
measure: Effective Regurgitant Orifice Area
timeFrame: 12 months
measure: Effective Regurgitant Orifice Area
timeFrame: 24 months
measure: Effective Regurgitant Orifice Area
timeFrame: 3 years
measure: Effective Regurgitant Orifice Area
timeFrame: 4 years
measure: Effective Regurgitant Orifice Area
timeFrame: 5 years
measure: Regurgitant Volume
timeFrame: Baseline
measure: Regurgitant Volume
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Regurgitant Volume
timeFrame: 6 months
measure: Regurgitant Volume
timeFrame: 12 months
measure: Regurgitant Volume
timeFrame: 24 months
measure: Regurgitant Volume
timeFrame: 3 years
measure: Regurgitant Volume
timeFrame: 4 years
measure: Regurgitant Volume
timeFrame: 5 years
measure: Regurgitant Fraction
timeFrame: Baseline
measure: Regurgitant Fraction
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Regurgitant Fraction
timeFrame: 6 months
measure: Regurgitant Fraction
timeFrame: 12 months
measure: Regurgitant Fraction
timeFrame: 24 months
measure: Regurgitant Fraction
timeFrame: 3 years
measure: Regurgitant Fraction
timeFrame: 4 years
measure: Regurgitant Fraction
timeFrame: 5 years
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: Baseline
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: 6 months
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: 12 months
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: 24 months
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: 3 years
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: 4 years
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: 5 years
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: Baseline
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 6 months
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 12 months
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 24 months
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 3 years
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 4 years
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 5 years
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: Baseline
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 6 months
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 12 months
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 24 months
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 3 years
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 4 years
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 5 years
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: Baseline
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 6 months
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 12 months
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 24 months
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 3 years
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 4 years
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 5 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 6 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 12 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 24 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 3 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 4 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 5 years
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: Baseline
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: 6 months
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: 12 months
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: 24 months
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: 3 years
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: 4 years
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: 5 years
measure: Mitral Valve Area
timeFrame: Baseline
measure: Mitral Valve Area
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Mitral Valve Area
timeFrame: 6 months
measure: Mitral Valve Area
timeFrame: 12 months
measure: Mitral Valve Area
timeFrame: 24 months
measure: Mitral Valve Area
timeFrame: 3 years
measure: Mitral Valve Area
timeFrame: 4 years
measure: Mitral Valve Area
timeFrame: 5 years
measure: Mean Mitral Valve Gradient
timeFrame: Baseline
measure: Mean Mitral Valve Gradient
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Mean Mitral Valve Gradient
timeFrame: 6 months
measure: Mean Mitral Valve Gradient
timeFrame: 12 months
measure: Mean Mitral Valve Gradient
timeFrame: 24 months
measure: Mean Mitral Valve Gradient
timeFrame: 3 years
measure: Mean Mitral Valve Gradient
timeFrame: 4 years
measure: Mean Mitral Valve Gradient
timeFrame: 5 years
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: Baseline
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 6 months
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 12 months
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 24 months
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 3 years
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 4 years
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 5 years
measure: Cardiac Output
timeFrame: Baseline
measure: Cardiac Output
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Cardiac Output
timeFrame: 6 months
measure: Cardiac Output
timeFrame: 12 months
measure: Cardiac Output
timeFrame: 24 months
measure: Cardiac Output
timeFrame: 3 years
measure: Cardiac Output
timeFrame: 4 years
measure: Cardiac Output
timeFrame: 5 years
measure: Forward Stroke Volume
timeFrame: Baseline
measure: Forward Stroke Volume
timeFrame: At discharge (or 30 days if discharge echocardiogram is not available)
measure: Forward Stroke Volume
timeFrame: 6 months
measure: Forward Stroke Volume
timeFrame: 12 months
measure: Forward Stroke Volume
timeFrame: 24 months
measure: Forward Stroke Volume
timeFrame: 3 years
measure: Forward Stroke Volume
timeFrame: 4 years
measure: Forward Stroke Volume
timeFrame: 5 years
measure: Kaplan-Meier Freedom From the Components of the Primary Safety Composite
timeFrame: 12 months in Device group
measure: Kaplan-Meier Freedom From the Components of the Primary Safety Composite
timeFrame: 24 months in Device group
measure: Kaplan-Meier Freedom From the Components of the Primary Safety Composite
timeFrame: 3 years in Device group
measure: Kaplan-Meier Freedom From the Components of the Primary Safety Composite
timeFrame: 4 years in Device group
measure: Kaplan-Meier Freedom From the Components of the Primary Safety Composite
timeFrame: 5 years in Device group
measure: Kaplan-Meier Freedom From the Primary Safety Composite
timeFrame: 24 months in Device group
measure: Kaplan-Meier Freedom From the Primary Safety Composite
timeFrame: 3 years in Device group
measure: Kaplan-Meier Freedom From the Primary Safety Composite
timeFrame: 4 years in Device group
measure: Kaplan-Meier Freedom From the Primary Safety Composite
timeFrame: 5 years in Device group
measure: Kaplan-Meier Freedom From All-cause Mortality
timeFrame: 24 months
measure: Kaplan-Meier Freedom From All-cause Mortality
timeFrame: 3 years
measure: Kaplan-Meier Freedom From All-cause Mortality
timeFrame: 4 years
measure: Kaplan-Meier Freedom From All-cause Mortality
timeFrame: 5 years
measure: Kaplan-Meier Freedom From Cardiovascular Mortality
timeFrame: 12 months
measure: Kaplan-Meier Freedom From Cardiovascular Mortality
timeFrame: 24 months
measure: Kaplan-Meier Freedom From Cardiovascular Mortality
timeFrame: 3 years
measure: Kaplan-Meier Freedom From Cardiovascular Mortality
timeFrame: 4 years
measure: Kaplan-Meier Freedom From Cardiovascular Mortality
timeFrame: 5 years
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization
timeFrame: 12 months
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization
timeFrame: 24 months
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization
timeFrame: 3 years
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization
timeFrame: 4 years
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization
timeFrame: 5 years
measure: Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
timeFrame: 12 months
measure: Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
timeFrame: 24 months
measure: Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
timeFrame: 3 years
measure: Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
timeFrame: 4 years
measure: Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
timeFrame: 5 years
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
timeFrame: 12 months
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
timeFrame: 24 months
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
timeFrame: 3 years
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
timeFrame: 4 years
measure: Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
timeFrame: 5 years
measure: NYHA Functional Class
timeFrame: Baseline
measure: NYHA Functional Class
timeFrame: 30 days
measure: NYHA Functional Class
timeFrame: 6 months
measure: NYHA Functional Class
timeFrame: 12 months
measure: NYHA Functional Class
timeFrame: 24 months
measure: NYHA Functional Class
timeFrame: 3 years
measure: NYHA Functional Class
timeFrame: 4 years
measure: NYHA Functional Class
timeFrame: 5 years
measure: Six-Minute Walk Test Distance (6MWD)
timeFrame: Baseline
measure: 6MWD
timeFrame: 30 days
measure: 6MWD
timeFrame: 6 months
measure: 6MWD
timeFrame: 12 months
measure: 6MWD
timeFrame: 24 months
measure: Change in 6MWD From Baseline
timeFrame: Between baseline and 30 days
measure: Change in 6MWD From Baseline
timeFrame: Between baseline and 6 months
measure: Change in 6MWD From Baseline
timeFrame: Between baseline and 12 months
measure: Change in 6MWD From Baseline
timeFrame: Between baseline and 24 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores
timeFrame: Baseline
measure: KCCQ QoL Scores
timeFrame: 30 days
measure: KCCQ QoL Scores
timeFrame: 6 months
measure: KCCQ QoL Scores
timeFrame: 12 months
measure: KCCQ QoL Scores
timeFrame: 24 months
measure: Change in KCCQ QoL Scores From Baseline
timeFrame: Between baseline and 30 days
measure: Change in KCCQ QoL Scores From Baseline
timeFrame: Between baseline and 6 months
measure: Change in KCCQ QoL Scores From Baseline
timeFrame: Between baseline and 12 months
measure: Change in KCCQ QoL Scores From Baseline
timeFrame: Between baseline and 24 months
measure: SF-36 QoL Scores
timeFrame: Baseline
measure: SF-36 QoL Scores
timeFrame: 30 days
measure: SF-36 QoL Scores
timeFrame: 6 months
measure: SF-36 QoL Scores
timeFrame: 12 months
measure: SF-36 QoL Scores
timeFrame: 24 months
measure: Change in SF-36 QoL Scores From Baseline
timeFrame: Between baseline and 30 days
measure: Change in SF-36 QoL Scores From Baseline
timeFrame: Between baseline and 6 months
measure: Change in SF-36 QoL Scores From Baseline
timeFrame: Between baseline and 12 months
measure: Change in SF-36 QoL Scores From Baseline
timeFrame: Between baseline and 24 months
measure: Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group
timeFrame: Through 5 years
measure: De Novo MitraClip Device Intervention in Control Group
timeFrame: Through 5 years
measure: Responder Analysis for 6MWD
timeFrame: 12 months
measure: Responder Analysis for 6MWD
timeFrame: 24 months
measure: Responder Analysis for LVEDV Index
timeFrame: 12 months
measure: Responder Analysis for LVEDV Index
timeFrame: 24 months
measure: Responder Analysis for LVEDV Index
timeFrame: 3 years
measure: Responder Analysis for LVEDV Index
timeFrame: 4 years
measure: Responder Analysis for LVEDV Index
timeFrame: 5 years
measure: Responder Analysis for QoL (KCCQ)
timeFrame: 12 months
measure: Responder Analysis for QoL (KCCQ)
timeFrame: 24 months
measure: Each Subscale for QoL (KCCQ)
timeFrame: 12 months
measure: Each Subscale for QoL (KCCQ)
timeFrame: 24 months
measure: Length of Index Hospitalization for MitraClip Procedure (Device Group)
timeFrame: Before MitraClip procedure on day 0
measure: Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular)
timeFrame: 12 months
measure: Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular)
timeFrame: 24 months
measure: Number of Days Alive and Out of Hospital
timeFrame: From the time of randomization to 12 months
measure: Number of Days Alive and Out of Hospital
timeFrame: From the time of randomization to 24 months
measure: Number of Days Alive and Out of Hospital
timeFrame: From the time of randomization to 3 Years
measure: Number of Days Alive and Out of Hospital
timeFrame: From the time of randomization to 4 Years
measure: Number of Days Alive and Out of Hospital
timeFrame: From the time of randomization to 5 Years
measure: Number of Days Hospitalized From the "Treatment" Visit
timeFrame: 12 months
measure: Number of Days Hospitalized From the "Treatment" Visit
timeFrame: 24 months
measure: Number of Days Hospitalized From the "Treatment" Visit
timeFrame: 3 Years
measure: Number of Days Hospitalized From the "Treatment" Visit
timeFrame: 4 Years
measure: Number of Days Hospitalized From the "Treatment" Visit
timeFrame: 5 Years
measure: Proportion of Alive Time in Hospital
timeFrame: 12 months
measure: Proportion of Alive Time in Hospital
timeFrame: 24 months
measure: Proportion of Alive Time in Hospital
timeFrame: 3 years
measure: Proportion of Alive Time in Hospital
timeFrame: 4 years
measure: Proportion of Alive Time in Hospital
timeFrame: 5 years
measure: Proportion of Subjects Living in the Baseline Location
timeFrame: 12 months
measure: Proportion of Subjects Living in the Baseline Location
timeFrame: 24 months
measure: Proportion of Subjects Living in the Baseline Location
timeFrame: 3 years
measure: Proportion of Subjects Living in the Baseline Location
timeFrame: 4 years
measure: Proportion of Subjects Living in the Baseline Location
timeFrame: 5 years
measure: Mitral Valve Replacement Rates
timeFrame: 12 months
measure: Mitral Valve Replacement Rates
timeFrame: 24 months
measure: Mitral Valve Replacement Rates
timeFrame: 3 years
measure: Mitral Valve Replacement Rates
timeFrame: 4 years
measure: Mitral Valve Replacement Rates
timeFrame: 5 years
measure: New Onset of Permanent Atrial Fibrillation
timeFrame: 12 months
measure: New Onset of Permanent Atrial Fibrillation
timeFrame: 24 months
measure: New Onset of Permanent Atrial Fibrillation
timeFrame: 3 years
measure: New Onset of Permanent Atrial Fibrillation
timeFrame: 4 years
measure: New Onset of Permanent Atrial Fibrillation
timeFrame: 5 years
measure: Mitral Stenosis
timeFrame: 12 months
measure: Mitral Stenosis
timeFrame: 24 months
measure: Mitral Stenosis
timeFrame: 3 years
measure: Mitral Stenosis
timeFrame: 4 years
measure: Mitral Stenosis
timeFrame: 5 years
measure: Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
timeFrame: 12 months
measure: Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
timeFrame: 24 months
measure: Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
timeFrame: 3 years
measure: Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
timeFrame: 4 years
measure: Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
timeFrame: 5 years
measure: Device-related Complications in Device Group Subjects and Control Group Subjects Who Undergo the MitraClip Procedure
timeFrame: Through 5 years
measure: Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
timeFrame: Baseline
measure: BNP or NT-proBNP Levels
timeFrame: 30 days
measure: BNP or NT-proBNP Levels
timeFrame: 12 months
measure: Modified Rankin Scale Score
timeFrame: Baseline
measure: Modified Rankin Scale Score
timeFrame: 30 days
measure: Modified Rankin Scale Score
timeFrame: 6 months
measure: Modified Rankin Scale Score
timeFrame: 12 months
measure: Major Bleeding
timeFrame: 30 days
measure: Prolonged Ventilation
timeFrame: 30 days
measure: Average Dosages of Guideline Directed Medical Therapy (GDMT)
timeFrame: Baseline
measure: Average Dosages of GDMT
timeFrame: 30 days
measure: Average Dosages of GDMT
timeFrame: 6 months
measure: Average Dosages of GDMT
timeFrame: 12 months
measure: Average Dosages of GDMT
timeFrame: 24 months
measure: Average Dosages of GDMT
timeFrame: 3 years
measure: Average Dosages of GDMT
timeFrame: 4 years
measure: Average Dosages of GDMT
timeFrame: 5 years
measure: The Number of Subjects With Changes in GDMT Dosage From Baseline
timeFrame: Between baseline and 30 days
measure: The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months
timeFrame: Between baseline and 6 months
measure: The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months
timeFrame: Between baseline and 12 months
measure: The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months
timeFrame: Between baseline and 24 months
measure: The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
timeFrame: Between baseline and 3 years
measure: The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
timeFrame: Between baseline and 4 years
measure: The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
timeFrame: Between baseline and 5 years
measure: The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
timeFrame: Between baseline and 30 days
measure: The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
timeFrame: Between baseline and 6 months
measure: The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
timeFrame: Between baseline and 12 months
measure: The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
timeFrame: Between baseline and 24 months
measure: The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
timeFrame: Between baseline and 3 years
measure: The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
timeFrame: Between baseline and 4 years
measure: The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
timeFrame: Between baseline and 5 years
measure: Cardiopulmonary Exercise (CPX) Testing
timeFrame: Baseline
measure: Cardiopulmonary Exercise (CPX) Testing
timeFrame: 12 months
measure: Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2
timeFrame: Between baseline and 12 months
measure: Health Economic Data
timeFrame: Through 5 years
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Hospitals
state: Arizona
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Sacramento
country: United States
facility: University California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco Hospital
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale - New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hosp Authority
state: Kansas
city: Wichita
country: United States
facility: Via Christi
state: Kansas
city: Lexington
country: United States
facility: St. Joseph's Hospital - Lexington, KY
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Foundation for Med Edu And Research
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Lincoln
country: United States
facility: Nebraska Heart Institute Heart Hospital
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center / New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: NYP Weill Cornell Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of University Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Austin
country: United States
facility: Seton Medical Center Austin
state: Texas
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center Cherry Hill Campus
state: Washington
city: Vancouver
country: Canada
facility: St Paul's - Providence Health Care
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Edmonton
country: Canada
facility: University of Alberta
Study officials:
affiliation: Baylor Health Care System
name: Michael Mack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Gregg Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ohio State University Heart Center
name: William T Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: JoAnn Lindenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giustino G, Camaj A, Kapadia SR, Kar S, Abraham WT, Lindenfeld J, Lim DS, Grayburn PA, Cohen DJ, Redfors B, Zhou Z, Pocock SJ, Asch FM, Mack MJ, Stone GW. Hospitalizations and Mortality in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial. J Am Coll Cardiol. 2022 Nov 15;80(20):1857-1868. doi: 10.1016/j.jacc.2022.08.803.
citation: Brener MI, Grayburn P, Lindenfeld J, Burkhoff D, Liu M, Zhou Z, Alu MC, Medvedofsky DA, Asch FM, Weissman NJ, Bax J, Abraham W, Mack MJ, Stone GW, Hahn RT. Right Ventricular-Pulmonary Arterial Coupling in Patients With HF Secondary MR: Analysis From the COAPT Trial. JACC Cardiovasc Interv. 2021 Oct 25;14(20):2231-2242. doi: 10.1016/j.jcin.2021.07.047.
citation: Kosmidou I, Lindenfeld J, Abraham WT, Rinaldi MJ, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Gaba P, Rogers JH, Shahim B, Redfors B, Zhang Z, Mack MJ, Stone GW. Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure. JACC Heart Fail. 2021 Sep;9(9):674-683. doi: 10.1016/j.jchf.2021.04.011. Epub 2021 Aug 11.
citation: Arnold SV, Stone GW, Jain SS, Mack MJ, Saxon JT, Zhang Z, Lindenfeld J, Abraham WT, Cohen DJ; COAPT Investigators. Prognostic Importance of Health Status Versus Functional Status in Heart Failure and Secondary Mitral Regurgitation. JACC Heart Fail. 2021 Sep;9(9):684-692. doi: 10.1016/j.jchf.2021.04.012. Epub 2021 Aug 11.
citation: Shahim B, Ben-Yehuda O, Chen S, Redfors B, Madhavan MV, Kar S, Lim DS, Asch FM, Weissman NJ, Cohen DJ, Arnold SV, Liu M, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Impact of Diabetes on Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: COAPT Trial. JACC Heart Fail. 2021 Aug;9(8):559-567. doi: 10.1016/j.jchf.2021.03.011.
citation: Kar S, Mack MJ, Lindenfeld J, Abraham WT, Asch FM, Weissman NJ, Enriquez-Sarano M, Lim DS, Mishell JM, Whisenant BK, Rogers JH, Arnold SV, Cohen DJ, Grayburn PA, Stone GW. Relationship Between Residual Mitral Regurgitation and Clinical and Quality-of-Life Outcomes After Transcatheter and Medical Treatments in Heart Failure: COAPT Trial. Circulation. 2021 Aug 10;144(6):426-437. doi: 10.1161/CIRCULATIONAHA.120.053061. Epub 2021 May 27.
citation: Gertz ZM, Herrmann HC, Lim DS, Kar S, Kapadia SR, Reed GW, Puri R, Krishnaswamy A, Gersh BJ, Weissman NJ, Asch FM, Grayburn PA, Kosmidou I, Redfors B, Zhang Z, Abraham WT, Lindenfeld J, Stone GW, Mack MJ. Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation and Response to MitraClip in the COAPT Trial. Circ Cardiovasc Interv. 2021 Apr;14(4):e010300. doi: 10.1161/CIRCINTERVENTIONS.120.010300. Epub 2021 Mar 15.
citation: Mack MJ, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant BK, Grayburn PA, Rinaldi MJ, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Rogers JH, Marx SO, Cohen DJ, Weissman NJ, Stone GW; COAPT Investigators. 3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure. J Am Coll Cardiol. 2021 Mar 2;77(8):1029-1040. doi: 10.1016/j.jacc.2020.12.047.
citation: Lindenfeld J, Abraham WT, Grayburn PA, Kar S, Asch FM, Lim DS, Nie H, Singhal P, Sundareswaran KS, Weissman NJ, Mack MJ, Stone GW; Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Investigators. Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes: A Secondary Analysis of the COAPT Trial. JAMA Cardiol. 2021 Apr 1;6(4):427-436. doi: 10.1001/jamacardio.2020.7200.
citation: Saxon JT, Cohen DJ, Chhatriwalla AK, Kotinkaduwa LN, Kar S, Lim DS, Abraham WT, Lindenfeld J, Mack MJ, Arnold SV, Stone GW. Impact of COPD on Outcomes After MitraClip for Secondary Mitral Regurgitation: The COAPT Trial. JACC Cardiovasc Interv. 2020 Dec 14;13(23):2795-2803. doi: 10.1016/j.jcin.2020.09.023.
citation: Kosmidou I, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant BK, Kipperman RM, Boudoulas KD, Redfors B, Shahim B, Zhang Z, Mack MJ, Stone GW. Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy: The COAPT Trial. Circ Heart Fail. 2020 Nov;13(11):e007293. doi: 10.1161/CIRCHEARTFAILURE.120.007293. Epub 2020 Nov 12.
citation: Giustino G, Lindenfeld J, Abraham WT, Kar S, Lim DS, Grayburn PA, Kapadia SR, Cohen DJ, Kotinkaduwa LN, Weissman NJ, Mack MJ, Stone GW. NYHA Functional Classification and Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: The COAPT Trial. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2317-2328. doi: 10.1016/j.jcin.2020.06.058.
citation: Hahn RT, Asch F, Weissman NJ, Grayburn P, Kar S, Lim S, Ben-Yehuda O, Shahim B, Chen S, Liu M, Redfors B, Medvedofsky D, Puri R, Kapadia S, Sannino A, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial. J Am Coll Cardiol. 2020 Sep 15;76(11):1305-1314. doi: 10.1016/j.jacc.2020.07.035.
citation: Grayburn PA, Sannino A, Cohen DJ, Kar S, Lim DS, Mishell JM, Whisenant BK, Rinaldi MJ, Kapadia SR, Rajagopal V, Crowley A, Kotinkaduwa LN, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial. J Am Coll Cardiol. 2020 Sep 1;76(9):1007-1014. doi: 10.1016/j.jacc.2020.07.010.
citation: Arnold SV, Stone GW, Mack MJ, Chhatriwalla AK, Austin BA, Zhang Z, Ben-Yehuda O, Kar S, Lim DS, Lindenfeld J, Abraham WT, Cohen DJ; COAPT Investigators. Health Status Changes and Outcomes in Patients With Heart Failure and Mitral Regurgitation: COAPT Trial. J Am Coll Cardiol. 2020 May 5;75(17):2099-2106. doi: 10.1016/j.jacc.2020.03.002. Epub 2020 Mar 16.
citation: Tang GHL. Echocardiographic Understanding of Secondary Mitral Regurgitation in Transcatheter Mitral Valve Repair: More to Learn. J Am Coll Cardiol. 2019 Dec 17;74(24):2980-2981. doi: 10.1016/j.jacc.2019.11.001. Epub 2019 Dec 9. No abstract available.
citation: Asch FM, Grayburn PA, Siegel RJ, Kar S, Lim DS, Zaroff JG, Mishell JM, Whisenant B, Mack MJ, Lindenfeld J, Abraham WT, Stone GW, Weissman NJ; COAPT Investigators. Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients With Secondary Mitral Regurgitation: The COAPT Trial. J Am Coll Cardiol. 2019 Dec 17;74(24):2969-2979. doi: 10.1016/j.jacc.2019.09.017. Epub 2019 Sep 28.
citation: Baron SJ, Wang K, Arnold SV, Magnuson EA, Whisenant B, Brieke A, Rinaldi M, Asgar AW, Lindenfeld J, Abraham WT, Mack MJ, Stone GW, Cohen DJ; COAPT Investigators. Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial. Circulation. 2019 Dec 3;140(23):1881-1891. doi: 10.1161/CIRCULATIONAHA.119.043275. Epub 2019 Sep 29.
citation: Arnold SV, Chinnakondepalli KM, Spertus JA, Magnuson EA, Baron SJ, Kar S, Lim DS, Mishell JM, Abraham WT, Lindenfeld JA, Mack MJ, Stone GW, Cohen DJ; COAPT Investigators. Health Status After Transcatheter Mitral-Valve Repair in Heart Failure and Secondary Mitral Regurgitation: COAPT Trial. J Am Coll Cardiol. 2019 May 7;73(17):2123-2132. doi: 10.1016/j.jacc.2019.02.010. Epub 2019 Mar 17.
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