New heart valve aims to improve tricuspid replacement outcomes

NCT ID NCT07684313

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

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study is testing a new artificial heart valve, called the TRIFORMIS RESILIA, for people who need their tricuspid valve replaced. The tricuspid valve controls blood flow between two right heart chambers. Researchers will follow 75 adults who receive this valve during surgery to see how well it works and how safe it is in real-world use. The study measures blood flow through the valve, heart function, and quality of life over time.

What this could mean

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

Active substance: Edwards TRIFORMIS RESILIA heart valve
What this could lead to: If successful, this study could confirm that the TRIFORMIS RESILIA valve works well and is safe for people needing tricuspid valve replacement, potentially improving heart function and quality of life.
What could go wrong: This is an observational study with no comparison group, so results may not prove the valve is better than other options. Risks include valve leakage, blood flow issues, or need for additional procedures.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart valve disorder tricuspid valve disorder

As listed by the trial registrant

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

CARDIOVASCULAR DISEASES HEART DISEASES HEART VALVE DISEASES TRICUSPID VALVE DISEASE

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Ascension St. Vincent's Hospital

Carmel, Indiana, 46260, United States

Contact

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