New heart valve fix without open surgery under Real-World watch

NCT ID NCT07409285

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry will follow 150 people with severe mitral regurgitation who receive the HighLife transcatheter mitral valve replacement system. The goal is to see how well the device works and how safe it is when used in everyday medical practice. Participants are treated according to standard instructions, and researchers will track outcomes like survival, valve function, and complications for up to 30 days.

What this could mean

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

Active substance: HighLife transcatheter mitral valve replacement system
What this could lead to: If successful, this registry could confirm that the HighLife system is a safe and effective option for treating severe mitral regurgitation without open-heart surgery.
What could go wrong: This is a post-market registry, not a randomized trial, so results may be less definitive. Risks include serious complications like stroke, bleeding, or need for additional procedures.

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 insufficiency

As listed by the trial registrant

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

MITRAL REGURGITATION

Contacts and locations

Locations

Universitätsklinikum Ulm

Ulm, Ulm, 89081, Germany

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