New heart valve device aims to fix tricuspid leak without open surgery
NCT ID NCT07528326
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.
Disclaimer
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
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