New catheter device aims to fix leaky heart valves without open surgery

NCT ID NCT04919980

Recruiting now Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

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.

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

As listed by the trial registrant

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

MITRAL VALVE REGURGITATION (DEGENERATIVE OR FUNCTIONAL)

Contacts and locations

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Locations

Ascension Saint Thomas
RECRUITING

Nashville, Tennessee, 37205, United States
Cedars-Sinai
RECRUITING

Los Angeles, California, 90048, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Cornell
WITHDRAWN

New York, New York, 10021, United States
Emory University
RECRUITING

Atlanta, Georgia, 30308, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 555905, United States
Morristown Medical Center
RECRUITING

Morristown, New Jersey, 07960, United States
Naples Comprehensive Health
RECRUITING

Naples, Florida, 34102, United States
NewYork-Presbyterian / Columbia University
RECRUITING

New York, New York, 10032, United States
Northwell Health
RECRUITING

Manhasset, New York, 11030, United States
Northwestern
RECRUITING

Chicago, Illinois, 60611, United States

Contact Email: •••••@•••••
OhioHealth Research Institute
RECRUITING

Columbus, Ohio, 43214, United States
Oregon Health & Science Universtiy
RECRUITING

Portland, Oregon, 97239, United States
Piedmont Heart Institute
RECRUITING

Atlanta, Georgia, 30309, United States
Saint Luke's Hospital
RECRUITING

Kansas City, Missouri, 64111, United States
Stanford University
RECRUITING

Palo Alto, California, 94305, United States
Swedish Medical Center
RECRUITING

Seattle, Washington, 98122, United States
University of Michigan Hospital and Health Systems
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37203, United States

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