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

NCT ID NCT07528326

Not yet recruiting Disease control Sponsor: TRiCares Source: ClinicalTrials.gov ↗

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

Summary

This study tests a new device called the TRiCares Topaz, which replaces the tricuspid heart valve without open surgery. It is for people with severe tricuspid regurgitation (a leaky valve) who still have symptoms despite medication. The study will compare this device to another approved device to see if it is safe and effective, measuring outcomes like survival, hospitalizations, 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: TRiCares Topaz transcatheter tricuspid heart valve replacement system
What this could lead to: If successful, this could provide a less invasive treatment option for people with severe tricuspid regurgitation, potentially reducing symptoms and hospitalizations.
What could go wrong: This is a large pivotal study, but the device is still experimental. Risks include major adverse events like death, heart failure, or need for another procedure. Long-term benefits are not yet proven.

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.

tricuspid valve insufficiency

As listed by the trial registrant

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

TRICUSPID REGURGITATION (TR)

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Other studies related to the condition(s) this trial covers.