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Transcatheter Mitral Valve System

Tendyne Transcatheter Mitral Valve System for Mitral Regurgitation (SUMMIT Trial)

N/A

Recruiting

Led By Jason Rogers, 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

NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)

Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)

Must not have

Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material

Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate the safety and effectiveness of a new device to treat mitral valve disease, compared to the current standard of care device. The trial will enroll patients who are not suitable for surgery, as well as those with severe mitral annular calcification.

Who is the study for?

This trial is for people with symptomatic mitral valve regurgitation or severe calcification who've been treated according to standards, are not in a vulnerable group, and have a life expectancy over 12 months. It's not for those with certain heart dimensions, previous mitral treatments, other severe valve diseases, or on hemodialysis.

What is being tested?

The SUMMIT trial compares the Tendyne Transcatheter Mitral Valve System to the MitraClip system in patients with moderate-to-severe mitral regurgitation. Some groups will only receive the Tendyne device. The study aims to assess safety and effectiveness through regular follow-ups over five years.

What are the potential side effects?

Potential side effects may include complications related to heart procedures like bleeding, infection risk at the catheter insertion site, irregular heartbeats, stroke risks or damage to surrounding structures such as blood vessels or other valves.

Eligibility Criteria

Inclusion Criteria

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

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My heart condition limits my physical activity but I can still walk.

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I have severe heart valve leakage or severe valve calcification.

Exclusion Criteria

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

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I have had surgery or a procedure on my mitral valve that involved putting in artificial material.

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I have a serious heart valve issue needing surgery.

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I need surgery or a catheter-based procedure for my aortic valve condition.

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I have no surgeries planned 60 days before or after joining the study.

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My non-heart related health issues are not expected to limit my life to under a year.

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I have a growth on my mitral heart valve.

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I am on hemodialysis for chronic kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-repairable Cohort

Randomized Cohort

Severe MAC Continued Access Protocol (MAC CAP) Cohort

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) CohortExperimental Treatment1 Intervention

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort

Group II: Severe Mitral Annular Calcification (MAC) CohortExperimental Treatment1 Intervention

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System

Group III: Randomized Cohort - Treatment GroupExperimental Treatment1 Intervention

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Group IV: Non-repairable CohortExperimental Treatment1 Intervention

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Group V: Randomized Cohort - Control GroupActive Control1 Intervention

Treatment of mitral regurgitation within commercially approved MitraClip system indications

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug