MitraClip System for Heart Failure (COAPT Trial)

Palo Alto (17 mi)

Overseen byMichael Mack, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My heart function test was done after my treatment was stable and any major changes.

I've been hospitalized for heart failure in the last year or have high BNP/NT-proBNP levels.

My heart failure markers were measured after my treatment was stable and any major changes.

My heart's pumping chamber size is within normal limits on a recent echo test.

My heart condition will be treated with medication, not surgery, as agreed by my medical team.

I am 18 years old or older.

I have some limitations on physical activity due to heart issues.

Exclusion Criteria

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.

I had a TAVR procedure within the last 30 days.

I have been diagnosed with the most advanced stage of heart failure.

I have a severe narrowing in my neck artery.

I have a serious heart artery problem that hasn't been treated yet.

I need home oxygen or take steroids daily for my COPD.

I need surgery for a heart valve problem.

I need surgery or a special procedure for my heart valve problem.

I have not had a heart bypass surgery in the last 30 days.

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.

Treatment Details

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.

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.

MitraClip System is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as MitraClip for: