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Massive registry launched to monitor new heart valve procedure

NCT ID NCT02245763

Knowledge-focused Sponsor: American College of Cardiology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 registry tracks the safety and real-world outcomes of a minimally invasive procedure to repair a leaky mitral valve (mitral regurgitation) using a device called a leaflet clip. It will enroll up to 4,000 patients across many hospitals. The goal is to monitor adverse events and understand how well the procedure works in everyday practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Leaflet Clip (device)
What this could lead to
If successful, this registry will provide real-world data on the safety and effectiveness of transcatheter mitral valve repair, helping guide future treatment decisions.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and reporting biases.

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.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Nov 2013

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Transcatheter Mitral Valve Repair must be furnished in a hospital with the appropriate infrastructre that includes, but is not limited to on site heart valve surgery program cardiac catheterization lab or hybrid operating room with a fixed radiographic imaging system with flat panel fluoroscopy, offering quality imaging non-invasive imaging such as echocardiography, vascular ultrasound, computed tomography and magnetic resonance. Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * All patients Exclusion Criteria: * Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen * Active endocarditis of the mitral valve * Rheumatic mitral valve disease * Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral valve regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • American College of Cardiology

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.