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Procedure

Percutaneous vs Surgical Repair for Mitral Valve Regurgitation (PRIMARY Trial)

N/A

Recruiting

Research Sponsored by Annetine Gelijns

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients ≥65 yrs with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography

Clinical indication for MV intervention and anatomic candidate for both MV transcatheter edge-to-edge and surgical repair per local heart team assessment

Must not have

Hypertrophic obstructive cardiomyopathy

Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two methods for repairing a damaged mitral valve in people with primary, degenerative mitral regurgitation. One method is called mitral valve transcatheter edge-to-edge repair, and the other is surgical repair. The trial will be conducted in the U.S., Canada, Germany and the United Kingdom.

Who is the study for?

This trial is for adults aged 65 or older with a specific heart valve condition called primary degenerative mitral regurgitation. Candidates must be able to perform physical tests and complete health questionnaires, and are eligible across all surgical risk levels. Exclusions include recent febrile illness, need for other heart surgeries, certain allergic reactions, bleeding disorders, prior mitral interventions, and severe co-existing conditions.

What is being tested?

The PRIMARY trial compares two treatments for mitral valve prolapse: a less invasive procedure called transcatheter edge-to-edge repair (TEER) versus traditional surgery. Participants will be randomly assigned to one of the two options in equal numbers at multiple centers internationally.

What are the potential side effects?

Potential side effects may vary between procedures but can include bleeding, infection risks associated with any heart procedure, possible allergic reactions to materials used during TEER or anesthesia complications from surgery.

Eligibility Criteria

Inclusion Criteria

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

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I am 65 or older with severe valve leakage as shown by an echo test.

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I am a candidate for a specific heart valve repair procedure as assessed by my heart care team.

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I can walk for 6 minutes and fill out a heart disease questionnaire.

Exclusion Criteria

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

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I have a thickened heart muscle that obstructs blood flow.

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I need surgery on my heart valves or aorta.

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My heart valve issue is not due to wear and tear.

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I have an active infection in my heart's lining.

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I do not have conditions that prevent me from using blood thinners.

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I need a procedure to improve blood flow to my heart.

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I need emergency surgery or intervention.

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I have a mass or clot inside my heart.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years post intervention 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, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 3+ MR (by transthoracic echocardiogram (TTE)) composite score.

Secondary study objectives

6 Minute Walk Test (6MWT)

Adequacy of MR correction

All-cause mortality

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