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

NCT ID NCT04820764

Recruiting now Disease control Sponsor: CardioMech AS Source: ClinicalTrials.gov ↗

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.

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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

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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