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

NCT ID NCT05751577

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

657 people

The number who actually took part.

Started

May 2023

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Severe aortic stenosis * Indication to TAVI confirmed by the Study Heart Team AND one of the following: * Inoperable due to prohibitive operative risk * High surgical risk as defined as STS score \>8% The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery: * Porcelain aorta or severely atherosclerotic aorta * Frailty/Reduced physical performance * Cognitive impairment, dementia, or Parkinson's disease * Severe liver disease/cirrhosis * Hostile chest * Internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum * Severe pulmonary hypertension and/or severe right ventricular dysfunction * Severe Chronic Obstructive Pulmonary Disease (COPD) * Age ≥85 years Exclusion Criteria: * Unsuitable for transfemoral TAVI * Emergent TAVI * Noncardiovascular comorbidity reducing life expectancy to \<1 year * Any factor precluding 1-year follow-up * Refusal informed consent

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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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