Can TAVI be done safely without a surgery team on standby?

NCT ID NCT05751577

Ongoing Knowledge-focused Sponsor: Azienda Usl di Bologna Source: ClinicalTrials.gov ↗

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

Summary

This study looks at whether a heart valve replacement procedure called TAVI can be safely performed in hospitals that do not have on-site cardiac surgery backup. It involves 657 patients with severe aortic stenosis who are at high risk for surgery. The same experienced doctors perform TAVI in both types of hospitals, and the study compares rates of death, stroke, and hospital readmission over one year.

What this could mean

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

What this could lead to: If successful, this could show that TAVI can be safely performed in centers without on-site cardiac surgery, expanding access to this procedure for more patients.
What could go wrong: This is a non-inferiority trial, not testing a new treatment. Results may not apply to less experienced teams or different patient populations. Emergent complications requiring surgery remain a risk.

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, SEVERE

Contacts and locations

Locations

Azienda Ospedaliera di Reggio Emilia

Reggio Emilia, Italy
Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy
Azienda ULSS 3 Serenissima, Ospedale di Mirano

Mirano, Italy
Azienda Unità Sanitaria Locale

Bologna, Bologna, 40100, Italy
Ospedale "Morgagni - Pierantoni" di Forlì

Forlì, Italy
Ospedale Cardinal Massaia di Asti

Asti, Italy
Ospedale Civile di Baggiovara

Modena, Italy
Ospedale Civile di Venezia SS Giovanni e Paolo

Venezia, Italy
Ospedale Guglielmo da Saliceto di Piacenza

Piacenza, Italy
Ospedale Infermi di Rimini

Rimini, Italy
Ospedale Misericordia di Grosseto

Grosseto, Italy
Ospedale San Donato di Arezzo

Arezzo, Italy
Ospedale Santa Maria delle Croci

Ravenna, Italy
Ospedale degli Infermi di Biella

Biella, Italy

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