New heart valve procedure could offer a gentler option for leaky valve patients

NCT ID NCT06608823

Recruiting now Disease control Sponsor: JenaValve Technology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study tests a new, less invasive way to replace a leaky aortic heart valve (aortic regurgitation) using a device called the JenaValve Trilogy, compared to standard open-heart surgery. About 1,000 people with moderate to severe aortic regurgitation will be randomly assigned to get either the new procedure or surgery. Researchers will track deaths, strokes, and unplanned heart-related hospital stays over 12 months to see if the new method is as safe and effective as surgery.

What this could mean

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

Active substance: JenaValve Trilogy transcatheter heart valve system
What this could lead to: If successful, this could offer a less invasive alternative to open-heart surgery for people with a leaky aortic valve, potentially reducing recovery time and hospital stays.
What could go wrong: This is a large trial but still experimental for this specific condition. The new device may not be as durable as surgical valves, and there are risks like stroke or need for rehospitalization.

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 insufficiency

As listed by the trial registrant

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

AORTIC INSUFFICIENCY AORTIC REGURGITATION AORTIC VALVE INSUFFICIENCY

Contacts and locations

Locations

Ascension St. Vincent Heart Center
RECRUITING

Carmel, Indiana, 46290, United States
BayCare Health
RECRUITING

Clearwater, Florida, 33756, United States
Baylor Scott & White Health
RECRUITING

Plano, Texas, 75074, United States
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02420, United States
Buffalo General Medical Center
RECRUITING

Buffalo, New York, 14203, United States
CPMC Sutter Health
RECRUITING

Burlingame, California, 94010, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Columbia University Medical Center
RECRUITING

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

Atlanta, Georgia, 30308, United States
HCA North Florida
RECRUITING

Gainesville, Florida, 32605, United States
Heart Care Centers of IL / Hinsdale Hospital
RECRUITING

Chicago, Illinois, 60521, United States
Henry Ford Health
RECRUITING

Detroit, Michigan, 48202, United States
Houston Methodist Research Institute
RECRUITING

Houston, Texas, 77030, United States
Intermountain Health
RECRUITING

Murray, Utah, 84107, United States
Lankenau Institute for Medical Research
RECRUITING

Philadelphia, Pennsylvania, 19096, United States
Los Robles Medical Center
RECRUITING

Thousand Oaks, California, 91360, United States
MedStar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Ohio Health
RECRUITING

Columbus, Ohio, 43214, United States
Oregon Health & Science University (OHSU)
RECRUITING

Portland, Oregon, 97239, United States
Piedmont Healthcare
RECRUITING

Atlanta, Georgia, 30369, United States
Robert Wood Johnson University Hospital
RECRUITING

New Brunswick, New Jersey, 08901, United States
Scripps Health
RECRUITING

La Jolla, California, 92037, United States
Sentara Norfolk
RECRUITING

Norfolk, Virginia, 23507, United States
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
University of Michigan
RECRUITING

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

Seattle, Washington, 98195, United States
Washington University - Barnes Jewish Hospital
RECRUITING

St Louis, Missouri, 63110, United States

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