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Heart valve study: could random placement be just as good?

NCT ID NCT05779787

Knowledge-focused Sponsor: Niguarda Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at people getting a new heart valve (TAVR) for a narrowed aortic valve. It compares two ways of placing the valve: one carefully aligned and one random. The goal is to see if the random method still allows doctors to easily reach the heart arteries later if needed. 100 participants will be followed to measure how well doctors can re-enter the arteries after the procedure.

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 a simpler, faster valve placement is just as good for allowing future heart procedures, potentially simplifying TAVR for many patients.
What could go wrong
This is a small, early-stage study (100 patients) looking at technical success, not long-term health outcomes. The results may not apply to all patients or valve types.

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 100 people

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

Started

Feb 2023

Expected to finish

May 2027

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

Consecutive patients with severe aortic stenosis diagnosed according to ESC guidelines, undergoing transcatheters aortic valve replacement with Navitor valve randomly implanted or Acurate Neo with commisural alignment technique

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.

Patients to be included in this registry should have all the following criteria: 1\. Severe, symptomatic aortic stenosis with an indication to TAVI Exclusion criteria and definition Patients excluded in this registry should have all the following criteria: 1. Valve in Valve procedure 2. Hemodynamical instability 3. TAVR performed from other access (not femoral) 4. No-CT Planned TAVR 5. TAVR performed with Chimney Technique

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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 Transcatheter aortic valve replacement

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

  • ASST GOM Niguarda

    RECRUITING

    Milan, Lombardy, 20162, Italy

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