Less invasive heart valve fix vs. open surgery: which is better for High-Risk patients?

NCT ID NCT05261204

ENROLLING_BY_INVITATION Disease control Sponsor: Centre Cardiologique du Nord Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two procedures for severe aortic valve stenosis: transcatheter aortic valve implantation (TAVI), a less invasive approach, and standard open-heart surgery. It will follow 4,000 high-risk patients for up to 24 months to see which method leads to fewer deaths, hospitalizations for heart failure, and valve problems. The goal is to determine if TAVI is a safer or more effective option for this group.

What this could mean

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

Active substance: Transcatheter aortic valve implantation (TAVI) device
What this could lead to: If TAVI proves better or equal to surgery, it could become the preferred option for high-risk patients, reducing recovery time and complications.
What could go wrong: This is an observational study, not a randomized trial, so results may be biased. TAVI carries risks like valve leakage or need for reoperation.

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.

aortic valve stenosis Prosthesis Failure

As listed by the trial registrant

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

PROSTHESIS SURVIVAL PROSTHESIS; CARDIAC, HEART, FUNCTIONAL DISTURBANCE AS RESULT

Contacts and locations

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Locations

Francesco Nappi

Saint-Denis, 93200, France

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