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

NCT ID NCT07604402

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times

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.

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

About 1,612 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 1. Severe aortic stenosis 2. Indication to TAVI confirmed by the Heart Team AND one of the following enrichment criteria: 1. Prohibitive operative risk 2. High surgical risk as defined as STS score \>8% 3. Porcelain aorta or severely atherosclerotic aorta 4. Frailty/Reduced physical performance 5. Severe liver disease/cirrhosis 6. Hostile chest and/or internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum 7. Severe pulmonary hypertension and/or severe right ventricular dysfunction 8. Age ≥85 years 9. Severe Chronic Obstructive Pulmonary Disease (COPD) The criteria listed above qualify the patient for eligibility in the study if present immediately after the heart team has indicated TAVI. However, this does not exclude patients without these criteria from entering the study if the heart team's evaluation still considers their risk/benefit profile appropriate for inclusion in the protocol. Exclusion criteria 1. Unsuitable for transfemoral TAVI 2. Emergent TAVI 3. Non-cardiovascular comorbidity reducing life expectancy to \<1 year 4. Any factor precluding 1-year follow-up 5. Refusal of 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria di Ferrara

    NOT_YET_RECRUITING

    Ferrara, Italy

  • Ospedale "L. Bonomo" - Andria - ASL Barletta Andria Trani

    RECRUITING

    Andria, Italy

  • Ospedale Maggiore CA Pizzardi, AUSL di Bologna

    RECRUITING

    Bologna, Italy

  • Ospedale Misericordia di Grosseto

    RECRUITING

    Grosseto, Italy

  • Ospedale Regionale San Salvatore

    RECRUITING

    L’Aquila, Italy

  • Ospedale Sacro Cuore Don Calabria, Negrar

    RECRUITING

    Verona, Italy

  • Ospedale San Donato

    RECRUITING

    Arezzo, Italy

  • Ospedale Santa Maria delle Croci, AUSL Romagna

    RECRUITING

    Ravenna, Italy

  • Ospedale Ss. Giovanni e Paolo

    RECRUITING

    Venezia, Italy

  • Ospedale degli Infermi di Rimini

    RECRUITING

    Rimini, Italy

  • Ospedale di Mirano

    RECRUITING

    Mirano, Italy

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