Can a tiny implant fix a leaky heart valve without open surgery?

NCT ID NCT06113354

Recruiting now Disease control Sponsor: Polares Medical SA Source: ClinicalTrials.gov ↗

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests a new device called the MRace implant, designed to reduce severe mitral regurgitation—a condition where the heart's mitral valve leaks blood backward. The implant is placed via a catheter through a vein in the leg, avoiding open-heart surgery. The study will enroll up to 10 patients in Brazil who are at high risk for conventional surgery. Researchers will evaluate whether the device is safe and can reduce the leak to a moderate or milder level.

What this could mean

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

Active substance: MRace Implant and Delivery System (transcatheter mitral valve repair device)
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe mitral regurgitation who are too high-risk for traditional surgery.
What could go wrong: This is an early feasibility study with only 10 patients, so results may not apply broadly. Risks include procedural complications, device failure, or no significant improvement in regurgitation.

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.

mitral valve disorder mitral valve insufficiency

As listed by the trial registrant

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

MITRAL VALVE DISEASE

Contacts and locations

Locations

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
RECRUITING

São Paulo, São Paulo, 05403-900, Brazil

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