New valve device could fix leaky heart valve without open surgery

NCT ID NCT06455787

Recruiting now Disease control Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new device called the J-Valve, which is a replacement heart valve delivered through a tube in the leg, to treat severe aortic regurgitation (a leaky heart valve). The trial will include 194 people with severe symptoms who are at high risk for open-heart surgery. The goal is to see if the device is safe and effective at improving heart function and quality of life.

What this could mean

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

Active substance: J-Valve Transfemoral (TF) System (a replacement heart valve delivered through a tube in the leg)
What this could lead to: If it works, this could offer a less invasive treatment option for people with severe aortic regurgitation who are too high-risk for open-heart surgery.
What could go wrong: This is an early study with no phase designation, so results are uncertain. Risks include death, stroke, bleeding, and need for a permanent pacemaker.

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.

aortic valve disorder aortic valve insufficiency

As listed by the trial registrant

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

AORTIC VALVE DISEASE MIXED AORTIC VALVE REGURGITATION

Contacts and locations

Locations

Ascension St. Thomas West Hospital
RECRUITING

Nashville, Tennessee, 37205, United States
Ascension Via Christi
RECRUITING

Wichita, Kansas, 67214, United States
Bay Area Structural Heart at Sutter Health
RECRUITING

San Francisco, California, 94109, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Cardiovascular Institute of the South
RECRUITING

Houma, Louisiana, 70360, United States
Carolinas Health System (Atrium)
RECRUITING

Charlotte, North Carolina, 28204, United States
Cedars Sinai
RECRUITING

Los Angeles, California, 90048, United States
CentraCare Heart and Vascular Center
RECRUITING

Saint Cloud, Minnesota, 56303, United States
Clinique Pasteur Toulouse
RECRUITING

Toulouse, 31076, France
Columbia University Irving Medical Center/New York-Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Emory University Atlanta
RECRUITING

Atlanta, Georgia, 30308, United States
Glenbrook - Endeavor Health
RECRUITING

Glenview, Illinois, 60026, United States
HCA Houston Healthcare Medical Center
RECRUITING

Houston, Texas, 77004, United States
Henry Ford Hospital Detroit
RECRUITING

Detroit, Michigan, 48202, United States
HonorHealth Research & Innovation Institute
RECRUITING

Scottsdale, Arizona, 85258, United States
Houston Methodist Hospital
RECRUITING

Houston, Texas, 77030, United States
Juntendo University Hospital
RECRUITING

Tokyo, Bunkyo-ku, 160-8582, Japan
Keio University Hospital
RECRUITING

Tokyo, Shinjuku-Ku, 160-8582, Japan
Massachusetts General Hospital Boston
RECRUITING

Boston, Massachusetts, 02114, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
NCH Rooney Heart Institute
RECRUITING

Naples, Florida, 34102, United States
Northwestern University Chicago
RECRUITING

Chicago, Illinois, 60611, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Oxford - John Radcliff Hospital
RECRUITING

Oxford, OX3 9DU, United Kingdom
Piedmont
RECRUITING

Atlanta, Georgia, 30309, United States
Scripps Memorial Hospital La Jolla
RECRUITING

La Jolla, California, 92037, United States
St. Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
St. Michael's Hospital
RECRUITING

Toronto, Ontario, M5B1W8, Canada
St. Paul's Hospital Vancouver
RECRUITING

Vancouver, British Columbia, V6Z1Y6, Canada
Stanford University Medical Center
RECRUITING

Palo Alto, California, 94394, United States
Swedish Heart & Vascular Research
RECRUITING

Seattle, Washington, 98122, United States
The Christ Hospital and The Carl & Edyth Lindner Center for Research and Education
RECRUITING

Cincinnati, Ohio, 45219, United States
The Heart Hospital - Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
UC Health Northern Colorado (Medical Center of the Rockies)
RECRUITING

Loveland, Colorado, 80538, United States
University at Buffalo - Kaleida Health
RECRUITING

Buffalo, New York, 14203, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94143, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Washington Hospital Center DC
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Washington University - Barnes-Jewish Hospital St. Louis
RECRUITING

St Louis, Missouri, 63110, United States

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