New heart valve fix without open surgery: early trial begins
NCT ID NCT06951672
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.
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
Phone: •••-•••-•••• Email: •••••@•••••
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Ascension St. Vincent
RECRUITINGIndianapolis, Indiana, 46260, United States
Contact
Contact Email: •••••@•••••
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Banner University Medical Center - Phoenix
RECRUITINGPhoenix, Arizona, 85006, United States
Contact Email: •••••@•••••
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Columbia University Medical Center (CUMC)
RECRUITINGNew York, New York, 10032, United States
Contact Email: •••••@•••••
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Intermountain Health
NOT_YET_RECRUITINGMurray, Utah, 84107, United States
Contact
Contact Email: •••••@•••••
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Methodist Hospital HCA
RECRUITINGSan Antonio, Texas, 78229, United States
Contact Email: •••••@•••••
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Montefiore Medical Center
NOT_YET_RECRUITINGThe Bronx, New York, 10467, United States
Contact
Contact Email: •••••@•••••
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Oregon Health & Science University (OHSU)
RECRUITINGPortland, Oregon, 97239, United States
Contact Email: •••••@•••••
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Piedmont Healthcare
NOT_YET_RECRUITINGAtlanta, Georgia, 30309, United States
Contact Email: •••••@•••••
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Saint Thomas Research Institute
NOT_YET_RECRUITINGNashville, Tennessee, 37205, United States
Contact Email: •••••@•••••
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Scripps Health
NOT_YET_RECRUITINGLa Jolla, California, 92037, United States
Contact Email: •••••@•••••
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University of Texas Health Science Center (UTH)
RECRUITINGHouston, Texas, 77030, United States
Contact
Contact Email: •••••@•••••