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New device aims to fix leaky heart valves without stopping the heart

NCT ID NCT02803957

Disease control Sponsor: NeoChord 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new device that repairs leaky mitral heart valves without stopping the heart or using a heart-lung machine, compared to standard open surgery. About 585 people with moderate to severe mitral regurgitation will take part. The goal is to see if the device is safer and works as well as traditional surgery.

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

About 585 people

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

Started

Nov 2016

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

21 years and older

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: * Is a candidate for mitral valve repair with cardiopulmonary bypass * Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation * Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram * Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement * Anatomic and general suitability Exclusion Criteria: * Prior mitral valve surgery * Concomitant cardiac procedures * Other cardiac procedures within 3 months

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Conditions

The condition(s) this trial relates to.

mitral valve disorder mitral valve insufficiency

As listed by the trial registrant

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

Mitral valve insufficiency

Contacts and locations

Locations

  • Baylor - Plano

    Plano, Texas, 75093, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Franciscan Health

    Indianapolis, Indiana, 46237, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • MedStar Washington Hospital Center

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

  • Mercy General Hospital

    Sacramento, California, 95819, United States

  • Mount Sinai, Icahn School of Medicine

    New York, New York, 10029, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30339, United States

  • Pinnacle Health

    Harrisburg, Pennsylvania, 17110, United States

  • St. Thomas

    Nashville, Tennessee, 37205, United States

  • Stanford University

    Stanford, California, 94305, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Valley Health System | Virginia

    Winchester, Virginia, 22601, United States

More trials for these conditions

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