New heart valve device aims to fix leaky tricuspid without open surgery

NCT ID NCT05913908

Recruiting now Disease control Sponsor: CroiValve Limited Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing a new device called the DUO System, which is placed through a catheter to reduce leakage in the tricuspid valve. The study will include 15 people with severe tricuspid regurgitation who still have symptoms despite medical therapy. The main goal is to see if the device is safe and works properly.

What this could mean

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

Active substance: DUO Transcatheter Tricuspid Coaptation Valve System (a device implanted via catheter to reduce tricuspid valve leakage)
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation who are not candidates for open-heart surgery.
What could go wrong: This is a very early feasibility study with only 15 participants, so results may not apply to everyone. The device could cause serious complications like bleeding, stroke, or heart damage.

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.

heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

HEART VALVE DISEASES TRICUSPID REGURGITATION TRICUSPID VALVE DISEASE TRICUSPID VALVE INSUFFICIENCY

Contacts and locations

Locations

Allina Health Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Ascension Via Christi Research
RECRUITING

Wichita, Kansas, 67214, United States
Columbia University Medical Center/NYPH
RECRUITING

New York, New York, 10032, United States
Dignity Health St. Joseph's Hospital & Medical Center
RECRUITING

Phoenix, Arizona, 85013, United States
Intermountain Health
RECRUITING

Salt Lake City, Utah, 84111, United States
Los Robles Hospital & Medical Center
RECRUITING

Thousand Oaks, California, 91360, United States
Medical University of Silesia
RECRUITING

Katowice, 40-635, Poland
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym
RECRUITING

Warsaw, Warsaw, 04-628, Poland
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
OhioHealth Research Institute
RECRUITING

Columbus, Ohio, 43214, United States
Piedmont Heart Institute
RECRUITING

Atlanta, Georgia, 30309, United States
San Antonio Methodist
ENROLLING_BY_INVITATION

San Antonio, Texas, 78229, United States
UPMC Pinnacle Harrisburg
RECRUITING

Harrisburg, Pennsylvania, 17050, United States
University of Washington
RECRUITING

Seattle, Washington, 98195, United States
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu
RECRUITING

Poznan, Poznan, 60-355, Poland

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