New heart valve device could help patients with heart pumps avoid open surgery

NCT ID NCT06594705

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

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study is testing a new heart valve device (JenaValve Trilogy) placed through a tube in an artery, without open surgery. It is for 50 adults who have a mechanical heart pump (LVAD) and also a leaky aortic valve that makes the pump work less effectively. The goal is to see if the device is safe and works well to fix the leak.

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 Heart Valve System (a replacement heart valve delivered through a catheter)
What this could lead to: If this works, it could provide a less invasive way to fix a leaky aortic valve in people who already have a heart pump, potentially improving their heart function and quality of life.
What could go wrong: This is a small, early-stage study with only 50 participants, so results may not apply to everyone. The procedure carries risks like bleeding, stroke, or the new valve not working as intended.

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 Disease aortic valve disorder aortic valve insufficiency left ventricular failure Ventricular Dysfunction, Left

As listed by the trial registrant

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

AORTIC INSUFFICIENCY AORTIC REGURGITATION AORTIC VALVE DISEASE AORTIC VALVE INSUFFICIENCY LEFT VENTRICULAR DYSFUNCTION

Contacts and locations

Locations

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States
Baylor

Plano, Texas, 75024, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, 10032, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Houston Methodist Research Center

Houston, Texas, 77030, United States
Intermountain

Murray, Utah, 84107, United States
Medstar Washington Hospital Center

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

Minneapolis, Minnesota, 55407, United States
Piedmont

Atlanta, Georgia, 30309, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Sutter Health

San Francisco, California, 94109, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
Washington University, St. Louis

St Louis, Missouri, 63130, United States

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