New heart valve fix without open surgery: early trial begins

NCT ID NCT06951672

Recruiting now Disease control Sponsor: Valcare Medical Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new device called the AMEND Trans-Septal System, which is designed to repair a leaky mitral valve without open-heart surgery. The device is implanted through a catheter, making it a safer option for older or sicker patients. Up to 15 people with severe, symptomatic mitral regurgitation will be enrolled to check safety and basic function over 30 days.

What this could mean

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

Active substance: AMEND Trans-Septal System (a device implanted through a catheter to repair the mitral valve)
What this could lead to: If successful, this could offer a less invasive way to repair leaky heart valves for people who are too frail for open-heart surgery.
What could go wrong: This is a very early, small study (only 15 people) focused on safety. The device may not work as intended, and there are risks like stroke or heart attack.

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 symptomatic heart failure

As listed by the trial registrant

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

SYMPTOMATIC FUNCTIONAL MR 3 OR GREATER

Contacts and locations

Locations

Ascension St. Vincent
RECRUITING

Indianapolis, Indiana, 46260, United States
Banner University Medical Center - Phoenix
RECRUITING

Phoenix, Arizona, 85006, United States
Columbia University Medical Center (CUMC)
RECRUITING

New York, New York, 10032, United States
Intermountain Health
NOT_YET_RECRUITING

Murray, Utah, 84107, United States
Methodist Hospital HCA
RECRUITING

San Antonio, Texas, 78229, United States
Montefiore Medical Center
NOT_YET_RECRUITING

The Bronx, New York, 10467, United States
Oregon Health & Science University (OHSU)
RECRUITING

Portland, Oregon, 97239, United States
Piedmont Healthcare
NOT_YET_RECRUITING

Atlanta, Georgia, 30309, United States
Saint Thomas Research Institute
NOT_YET_RECRUITING

Nashville, Tennessee, 37205, United States
Scripps Health
NOT_YET_RECRUITING

La Jolla, California, 92037, United States
University of Texas Health Science Center (UTH)
RECRUITING

Houston, Texas, 77030, United States