Heart valve fix without a surgery center? major trial tests safety

NCT ID NCT07604402

Recruiting now Disease control Sponsor: University Hospital of Ferrara Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a common heart valve procedure called TAVI can be performed safely in hospitals that do not have on-site cardiac surgery backup. About 1,600 patients with severe aortic stenosis will be randomly assigned to get TAVI either at a center with or without on-site surgery. The goal is to see if the outcomes are similar after one year, which could expand access to this life-saving treatment.

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) procedure
What this could lead to: If successful, this could allow more hospitals to offer TAVI, making life-saving heart valve treatment accessible to more patients without needing a full cardiac surgery center.
What could go wrong: This is a large trial but still testing safety in a new setting. There is a risk that outcomes in centers without on-site surgery may be worse, and the study may not prove non-inferiority.

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

As listed by the trial registrant

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

AORTIC STENOSIS

Contacts and locations

Locations

Azienda Ospedaliero Universitaria di Ferrara
NOT_YET_RECRUITING

Ferrara, Italy
Ospedale Ss. Giovanni e Paolo
RECRUITING

Venezia, Italy
Ospedale di Mirano
RECRUITING

Mirano, Italy

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