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Procedure

TMCA for Mitral Regurgitation

N/A

Waitlist Available

Led By Robert J Lederman, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

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

Must have

Symptomatic functional mitral valve regurgitation

Adults age >=21 years

Must not have

Aortic stenosis more than mild in severity

Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30 post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trialtests a new device & technique to treat functional mitral valve regurgitation, instead of surgery, to reduce symptoms & hospital admissions.

Who is the study for?

This trial is for adults over 21 with functional mitral valve regurgitation, a heart condition causing leakage and failure. Participants must have symptoms like breathlessness or fluid buildup, be on stable heart medication for at least a month, and have specific heart function levels. Those who've had certain previous treatments like MitraClip can join if it's been over 30 days.

What is being tested?

The study tests a new catheter-based technique called Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat mitral valve leakage without surgery. It involves implanting devices that tighten around the valve to prevent leakage while protecting coronary arteries from being squeezed.

What are the potential side effects?

Potential side effects may include complications related to device implantation such as bleeding or infection, adverse reactions to X-ray and ultrasound used during the procedure, and possible impact on nearby heart structures.

Eligibility Criteria

Inclusion Criteria

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

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I have symptoms from a leaking mitral valve in my heart.

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I am 21 years old or older.

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I have heart valve issues, reduced heart function, and severe heart failure symptoms.

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I have moderate or severe leakage in my heart valve and symptoms of heart failure.

Exclusion Criteria

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

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I have moderate to severe aortic stenosis.

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I am scheduled for a heart valve surgery.

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I am unable to give consent for participation on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30 post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 post procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The Primary Endpoint is Technical Success

Secondary study objectives

The Secondary Endpoint is Procedural Success

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcatheter Mitral Valve Cerclage AnnuloplastyExperimental Treatment1 Intervention

To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy. The TMCA implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery.

0 / 7Eligibility criteria met