New heart valve replacement without open surgery shows early promise

NCT ID NCT06506942

Recruiting now Disease control Sponsor: TRiCares Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This early study is testing a new device called the TRiCares Topaz, which is threaded through a vein to replace the tricuspid valve in the heart. It is for adults with severe tricuspid valve leakage who are not good candidates for open-heart surgery. The study will check if the device is safe and works as intended, focusing on reducing valve leakage and improving patients' ability to walk and their heart failure symptoms.

What this could mean

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

Active substance: TRiCares Topaz Tricuspid Valve Replacement System (a device implanted via catheter to replace the leaky tricuspid valve)
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe tricuspid valve leakage who are too high-risk 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 procedure carries risks like bleeding, infection, or device complications.

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.

cardiovascular disorder heart valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

CARDIOVASCULAR DISEASES HEART VALVE DISEASES TRICUSPID VALVE REGURGITATION

Contacts and locations

Locations

Columbia University Medical Center/ NewYork Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Montefiore
RECRUITING

The Bronx, New York, 10461, United States
Northwestern
RECRUITING

Chicago, Illinois, 60611, United States
Piedmont Healthcare Inc.
RECRUITING

Atlanta, Georgia, 30309, United States
St. Michaels Hospital
RECRUITING

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

Vancouver, British Columbia, V6Z1Y6, Canada
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
University of Michigan Hospital and Health Systems
RECRUITING

Ann Arbor, Michigan, 48109, United States

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