New catheter device aims to fix leaky heart valves without open surgery
NCT ID NCT04919980
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new device called the INNOVALVE system for people with a leaky mitral valve who are too high-risk for open-heart surgery. The device is delivered through a catheter to repair the valve. Researchers will check if it is safe and works well in 65 participants 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
INNOVALVE system (a device implanted via catheter to repair the mitral valve)
What this could lead to
If it works, this could offer a less invasive treatment option for people with leaky mitral valves who cannot undergo open-heart surgery.
What could go wrong
This is an early feasibility study with only 65 participants, so results may not apply broadly. The device could cause serious side effects or fail to improve symptoms.
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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Ascension Saint Thomas
RECRUITINGNashville, Tennessee, 37205, United States
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Cedars-Sinai
RECRUITINGLos Angeles, California, 90048, United States
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Cornell
WITHDRAWNNew York, New York, 10021, United States
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Emory University
RECRUITINGAtlanta, Georgia, 30308, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Mayo Clinic
RECRUITINGRochester, Minnesota, 555905, United States
Contact Email: •••••@•••••
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Morristown Medical Center
RECRUITINGMorristown, New Jersey, 07960, United States
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Naples Comprehensive Health
RECRUITINGNaples, Florida, 34102, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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NewYork-Presbyterian / Columbia University
RECRUITINGNew York, New York, 10032, United States
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Contact Email: •••••@•••••
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Northwell Health
RECRUITINGManhasset, New York, 11030, United States
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Northwestern
RECRUITINGChicago, Illinois, 60611, United States
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OhioHealth Research Institute
RECRUITINGColumbus, Ohio, 43214, United States
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Oregon Health & Science Universtiy
RECRUITINGPortland, Oregon, 97239, United States
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Piedmont Heart Institute
RECRUITINGAtlanta, Georgia, 30309, United States
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Saint Luke's Hospital
RECRUITINGKansas City, Missouri, 64111, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Stanford University
RECRUITINGPalo Alto, California, 94305, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Swedish Medical Center
RECRUITINGSeattle, Washington, 98122, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University of Michigan Hospital and Health Systems
RECRUITINGAnn Arbor, Michigan, 48109, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37203, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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