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Device

Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation

N/A

Recruiting

Led By Patrick McCarthy, 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

The cardiac surgeon of the Site Heart Team has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild

Subject is ≥ 18 years of age

Must not have

Active infections requiring current antibiotic therapy

Concomitant severe tricuspid valve regurgitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the effectiveness of two treatments for severe primary MR in patients who are at moderate surgical risk.

Who is the study for?

This trial is for adults with severe primary mitral valve regurgitation who are at moderate surgical risk. Candidates must be suitable for both MitraClip device implantation and surgery, as confirmed by a heart team. They may have symptoms or certain heart function measurements that indicate treatment is needed. People with active infections, renal failure on dialysis, severe mitral annular calcification, or those needing other cardiac surgeries are excluded.

What is being tested?

The study compares the MitraClip device implantation to traditional surgical repair in patients with severe primary mitral valve regurgitation. It's a randomized controlled trial where participants will be assigned to one of these treatments based on chance.

What are the potential side effects?

Potential side effects can include complications from the procedure like bleeding or infection, issues related to heart function changes post-treatment, and general risks associated with any invasive cardiac procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart surgeon agrees I can have mitral valve surgery and my valve is right for a specific clip procedure.

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I am 18 years old or older.

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I have severe mitral valve regurgitation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking antibiotics for an infection.

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I have severe leakage in my heart's tricuspid valve.

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My femoral vein is too small for a 24 F catheter or I have an IVC filter/DVT that could interfere.

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I need emergency surgery.

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I do not have severe heart issues like very low blood pressure, shock, or need for heart support devices.

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I have severe hardening of the heart's mitral valve ring.

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I have a type of heart valve issue called secondary MR.

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I have had surgery or a procedure on my mitral valve, or I have a mechanical heart valve or device.

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I have been diagnosed with thickened heart muscles.

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I require dialysis for kidney failure.

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I need heart surgery for a valve problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded)

Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)

Secondary study objectives

Number of days at hospital from index procedure to home discharge

Proportion of subjects discharged to home post index hospitalization

Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors

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