New heart valve fix could spare patients from Open-Heart surgery
NCT ID NCT05061004
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests a new device called the Cephea Mitral Valve System for people with a leaky or narrowed mitral heart valve. The goal is to see if it is safe and works well for patients who are not good candidates for open-heart surgery. About 50 people will get the device and be followed for 30 days to check for serious problems and whether the valve leak is reduced.
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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
Locations
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Allegheny General Hospital - ASRI
RECRUITINGPittsburgh, Pennsylvania, 15212, United States
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Ascension Saint Thomas
RECRUITINGNashville, Tennessee, 37205, United States
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Ascension Via Christi Hospitals Wichita
RECRUITINGWichita, Kansas, 67214, United States
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Atrium Health - Carolinas Medical Center
RECRUITINGCharlotte, North Carolina, 28203, United States
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Banner-University Medical Center Phoenix
RECRUITINGPhoenix, Arizona, 85006, United States
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30308, United States
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Houston Methodist
RECRUITINGHouston, Texas, 77030, United States
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IUCPQ-ULaval
WITHDRAWNQuébec, Quebec, G1V 4G5, Canada
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Institut de Cardiologie de Montreal
COMPLETEDMontreal, Quebec, Canada
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Los Robles Regional Medical Center
RECRUITINGThousand Oaks, California, 91360, United States
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Minneapolis Heart Institute
RECRUITINGMinneapolis, Minnesota, 55407, United States
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Montefiore Medical Center - Moses Campus
RECRUITINGThe Bronx, New York, 10467, United States
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New York-Presbyterian/Columbia University Medical Center
RECRUITINGNew York, New York, 10032, United States
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Northwestern Memorial Hospital
RECRUITINGChicago, Illinois, 60611, United States
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Piedmont Heart Institute
RECRUITINGAtlanta, Georgia, 30309, United States
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Sentara Norfolk General Hospital
RECRUITINGNorfolk, Virginia, 23507, United States
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Swedish Medical Center
RECRUITINGSeattle, Washington, 98122, United States
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The Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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University of California - Davis Medical Center
RECRUITINGSacramento, California, 95817, United States
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University of Michigan - Davis Medical Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
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Vanderbilt Heart & Vascular Institute
RECRUITINGNashville, Tennessee, 37208, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI ultrasound could unmask silent heart disease in seniors
- Can a new valve device fix a leaky heart without open surgery?
- Can mixed reality make heart valve surgery safer and faster?
- A painless, contact-free vibration sensor may detect hidden heart and lung problems
- New heart valve device could spare High-Risk patients from Open-Heart surgery
- First-in-Human trial aims to offer new hope for patients with leaky heart valves who Can't have surgery