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Percutaneous Therapy

MitraClip System for Heart Failure (COAPT Trial)

N/A
Waitlist Available
Led By Michael Mack, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 a greater than 100% increase or greater than 50% decrease in dose of GDMT, 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%).
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).
Must not have
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, Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site, Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration, Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.
Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation in Symptomatic Heart Failure Subjects. It is a randomized controlled trial with 610 subjects. A subset of patients will also be registered in a cardiopulmonary exercise sub-study.

Who is the study for?
This trial is for adults with symptomatic heart failure and moderate-to-severe functional mitral regurgitation who are not suitable for surgery. They should have been hospitalized for heart failure or have certain levels of natriuretic peptides, indicating heart stress. Patients must be stable on optimal medical therapy and capable of giving informed consent.
What is being tested?
The COAPT Trial tests the safety and effectiveness of the MitraClip System in reducing mitral regurgitation in patients with heart failure. It's a randomized controlled trial where some patients receive the device while others continue standard care without it.
What are the potential side effects?
Potential side effects from the MitraClip procedure may include bleeding at the access site, infection, complications related to catheter insertion like blood vessel damage, arrhythmias (irregular heartbeat), or worsening of kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart function test was done after my treatment was stable and any major changes.
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I've been hospitalized for heart failure in the last year or have high BNP/NT-proBNP levels.
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My heart failure markers were measured after my treatment was stable and any major changes.
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My heart's pumping chamber size is within normal limits on a recent echo test.
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My heart condition will be treated with medication, not surgery, as agreed by my medical team.
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I am 18 years old or older.
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I have some limitations on physical activity due to heart issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have certain heart conditions that make it unsafe for you to participate in the study. These include high blood pressure in the lungs, specific types of heart muscle diseases, unstable heart function, or recent heart device implantation.
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I had a TAVR procedure within the last 30 days.
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I have been diagnosed with the most advanced stage of heart failure.
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I have a severe narrowing in my neck artery.
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I have a serious heart artery problem that hasn't been treated yet.
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I need home oxygen or take steroids daily for my COPD.
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I need surgery for a heart valve problem.
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I need surgery or a special procedure for my heart valve problem.
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I have not had a heart bypass surgery in the last 30 days.
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Criterion: Your heart valve and overall health should not have certain issues that would prevent the MitraClip device from being implanted or working properly. These issues include: not enough mobile leaflet for the device, calcification in the grasping area, significant cleft in the grasping area, lack of chordal support, short leaflet mobility, unstable blood pressure, need for urgent or planned cardiac surgery, life expectancy less than 12 months due to non-heart conditions, severe disability, prior heart transplant or valve surgery, presence of heart masses or infections, allergic reactions to certain medications, pregnancy or planning to become pregnant soon, participating in another research study, or inability to give consent or follow study procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint
Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months
Secondary study objectives
Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)
Change in Left Ventricular End Diastolic Volume (LVEDV)
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
+12 more
Other study objectives
6MWD
Cardiac Output
Cardiopulmonary Exercise (CPX) Testing
+42 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MitraClip SystemExperimental Treatment1 Intervention
Percutaneous mitral valve repair using MitraClip System
Group II: COAPT CAS GroupExperimental Treatment1 Intervention
Percutaneous mitral valve repair using MitraClip System
Group III: Control GroupActive Control1 Intervention
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
650 Previous Clinical Trials
410,570 Total Patients Enrolled
126 Trials studying Heart Failure
51,975 Patients Enrolled for Heart Failure
Michael Mack, MDPrincipal InvestigatorBaylor Health Care System
5 Previous Clinical Trials
1,746 Total Patients Enrolled
Gregg Stone, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
13 Previous Clinical Trials
4,623 Total Patients Enrolled
1 Trials studying Heart Failure
129 Patients Enrolled for Heart Failure

Media Library

MitraClip System (Percutaneous Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01626079 — N/A
Heart Failure Research Study Groups: MitraClip System, Control Group, COAPT CAS Group
Heart Failure Clinical Trial 2023: MitraClip System Highlights & Side Effects. Trial Name: NCT01626079 — N/A
MitraClip System (Percutaneous Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01626079 — N/A
~59 spots leftby Nov 2025
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