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New heart valve study aims to improve survival in aortic stenosis patients

NCT ID NCT07359898

Disease control Sponsor: IRCCS Policlinico S. Donato 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study is testing the Navitor heart valve in 1000 people with severe aortic stenosis, a condition where the heart's main valve narrows. Participants receive the valve through a catheter, and researchers track survival and complications for one year. The goal is to see how well the valve works in everyday medical practice.

What this could mean

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

Active substance
Navitor/Navitor Vision transcatheter aortic valve
What this could lead to
If successful, this could confirm that the Navitor valve is safe and effective for treating severe aortic stenosis in a broad patient population.
What could go wrong
This is an observational study without a comparison group, so results may not prove the valve is better than other options. Risks include complications from the valve implant procedure, such as bleeding or stroke.

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

About 1,000 people

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

Started

Oct 2025

Expected to finish

Oct 2031

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.

Who is studied

This Study will enroll subjects of all genders who have symptomatic severe AS, either in a native valve or in a surgical bioprosthetic valve, and who have an indication for TAVI. The latter may also be predominantly regurgitant and remain suitable for enrolment.

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: 1. Subject is referred to undergo TAVI with a Navitor/Navitor Vision valve according to the local Heart Team. The Heart Team determines the indication for TAVI with Navitor/Navitor Vision before possible enrolment and independently of the study. 2. Subject is of legal age for consent in the host country. 3. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical site. Exclusion Criteria: 1. Pregnant or nursing subjects 2. Need for emergency surgery for any reason 3. Contraindications to Navitor/Navitor Vision TAVI according to the IFU: 1. Any sepsis, including active endocarditis 2. Any evidence of left ventricular or atrial thrombus 3. Vascular conditions (i.e., stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve impossible 4. Non-calcified aortic annulus 5. Any leaflet configuration other than tricuspid 6. Inability to tolerate antiplatelet/anticoagulant therapy 4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, individuals with severe dementia or individuals without legal authority 5. Individuals who are unable to read or write

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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.

Severe native 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

    1 site. 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

  • IRCCS Policlinico San Donato

    RECRUITING

    San Donato Milanese, Lombardy, 20097, Italy