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New catheter procedure tightens leaky heart valves without surgery

NCT ID NCT03929913

Disease control Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested a new, less invasive procedure to treat functional mitral regurgitation, a condition where a leaky heart valve causes heart failure symptoms like shortness of breath and fatigue. Nineteen adults with this condition received a permanently implanted device that tightens the valve like a purse-string, using catheters guided by X-ray and ultrasound, avoiding open-heart surgery. The goal was to see if the procedure could be done safely and effectively, with success measured immediately and at 30 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

19 people

The number who actually took part.

Started

May 2019

Finished

Feb 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: 1. Adults age \>=21 years 2. Symptomatic functional mitral valve regurgitation 1. Mild or greater mitral valve regurgitation, LVEF \<= 0.50, and NYHA class III - IV heart failure 2. Moderate or greater mitral valve regurgitation and NYHA II - IV heart failure, irrespective of LV systolic function 3. On optimal medical therapy for at least one month 4. Left ventricular ejection fraction \>=0.20 assessed by echocardiography, CT, or CMR 5. Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on pre-procedural cardiac CT or coronary venogram 6. Concordance of the Study Eligibility Committee 7. If present, a MitraClip was implanted at least 30 days previously EXCLUSION CRITERIA: 1. Subjects unable to consent to participate 2. Subjects unwilling to participate or unwilling to return for study follow-up activities. 3. Prior cardiac implanted electronic devices (CIED) likely to be entrapped by cerclage. \-- Candidates with coronary sinus or left ventricular pacing or defibrillation leads that are not likely to be entrapped by cerclage, evident on baseline CT or angiogram, are eligible to participate. 4. TAVR within 6 weeks 5. Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention 6. Aortic stenosis more than mild in severity 7. Single-leaflet MitraClip detachment, if present 8. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures

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Conditions

The condition(s) this trial relates to.

heart failure mitral valve insufficiency Ventricular Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional mitral regurgitation

Contacts and locations

Locations

  • Carilion Medical Center

    Roanoke, Virginia, 24014, United States

  • Emory University

    Atlanta, Georgia, 30322-1102, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

More trials for these conditions

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