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New catheter device aims to repair leaky mitral valves in high-risk patients

NCT ID NCT04820764

Disease control Sponsor: CardioMech AS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests a new device called the CardioMech Mitral Valve Repair System in 25 people with moderate to severe mitral regurgitation (a leaky heart valve) who are at intermediate or high risk for surgery. The device is delivered through a catheter to repair the valve without open-heart surgery. The main goals are to check safety and see if the device reduces the leak.

What this could mean

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

Active substance
CardioMech Mitral Valve Repair System (a device implanted via catheter to repair the mitral valve)
What this could lead to
If successful, this device could offer a less invasive treatment option for people with leaky mitral valves who are too high-risk for open-heart surgery.
What could go wrong
This is a very early feasibility study with only 25 people, so results may not apply to everyone. The device could cause serious side effects or fail to improve valve function.

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 25 people

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

Started

Jul 2021

Expected to finish

Sep 2031

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

18 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: * Eighteen (18) years of age or greater * Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail * Intermediate or high surgical risk for mitral valve repair Exclusion Criteria: * History of rheumatic heart disease * History of prior endocarditis * History of prior repair or replacement of the mitral valve, or annuloplasty * Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment * Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging

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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 regurgitation

How to take part

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

  1. The places running it

    10 sites. 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

  • Ascension St. Francis via Christi

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Ascension St. Thomas West

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Atrium Health Sanger Heart and Vascular Institute

    ACTIVE_NOT_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Baylor Scott & White, The Heart Hospital

    RECRUITING

    Plano, Texas, 75093, United States

  • Cardiovascular Institute of Los Robles Health System

    ACTIVE_NOT_RECRUITING

    Thousand Oaks, California, 91360, United States

  • CentraCare Heart & Vascular Center

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

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