New catheter device aims to repair leaky mitral valves in high-risk patients
NCT ID NCT04820764
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
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Locations
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Ascension St. Francis via Christi
RECRUITINGWichita, Kansas, 67226, United States
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Ascension St. Thomas West
RECRUITINGNashville, Tennessee, 37205, United States
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Atrium Health Sanger Heart and Vascular Institute
ACTIVE_NOT_RECRUITINGCharlotte, North Carolina, 28204, United States
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Baylor Scott & White, The Heart Hospital
RECRUITINGPlano, Texas, 75093, United States
Contact Email: •••••@•••••
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Cardiovascular Institute of Los Robles Health System
ACTIVE_NOT_RECRUITINGThousand Oaks, California, 91360, United States
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CentraCare Heart & Vascular Center
RECRUITINGSaint Cloud, Minnesota, 56303, United States
Contact Email: •••••@•••••
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Intermountain Medical Center
RECRUITINGMurray, Utah, 84107, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55902, United States
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NYU Langone
RECRUITINGNew York, New York, 10016, United States
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Northwestern University
RECRUITINGEvanston, Illinois, 60208, United States
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The Christ Hospital
RECRUITINGCincinnati, Ohio, 45219, United States
Contact Email: •••••@•••••
Contact