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New heart valve procedure shows promise for Low-Risk patients

NCT ID NCT07605780

Disease control Sponsor: Centro Cardiologico Monzino 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 650 low-risk patients with severe aortic valve narrowing who received a less invasive valve replacement called TAVI. Researchers tracked deaths, strokes, and return hospital visits for heart problems. The goal was to see how well TAVI works in everyday practice for people not at high surgical 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.

Participants

650 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2025

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.

Who is studied

Consecutive patients with symptomatic severe aortic valve stenosis and low surgical risk-defined as an STS-PROM score (Society of Thoracic Surgeons Predicted Risk of Mortality for isolated SAVR) of less than 4% and no major organ damage-who were treated with TAVI.

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: * Patients aged 18 years or older * Patients with severe symptomatic aortic valve stenosis undergoing TAVI. * Patients considered to be at low surgical risk, defined as an STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality for isolated SAVR) score of less than 4% and no major organ damage. Exclusion Criteria: * Patients who required emergency aortic valve replacement for any reason * Need for conversion to SAVR during the procedure * Patients who refused to consent to participate in the study

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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 valve stenosis

Contacts and locations

Locations

  • Fondazione Poliambulanza Istituto Ospedaliero, Unità Emodinamica

    Brescia, BS, 25124, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.