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New heart valve under 10-Year watch: will it last?

NCT ID NCT06953206

Disease control Sponsor: Institut für Pharmakologie und Präventive Medizin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This registry will follow 500 adults with severe aortic stenosis who receive a SAPIEN 3 Ultra Resilia heart valve through a minimally invasive procedure. Researchers will track how well the valve works and how safe it is over 10 years. The goal is to see if this newer valve design holds up better over time.

What this could mean

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

Active substance
SAPIEN 3 Ultra Resilia heart valve
What this could lead to
If successful, this registry could confirm that the SAPIEN 3 Ultra Resilia valve is durable and safe over 10 years, helping doctors choose the best valve for patients with aortic stenosis.
What could go wrong
This is an observational registry, not a controlled trial, so results may not prove the valve is better than others. Valve failure or complications could still occur over time.

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 500 people

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

Started

Sep 2025

Expected to finish

Sep 2037

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Adult patiets with severe aortic stenosis planned to undergo TAVR on their native valve with a SAPIEN 3 Ultra RESILIA Valve.

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: * Adult patients (≥18 years) * Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve * Patient is willing to attend the follow-up visits up to 10 years at the center Exclusion criteria: * Lack of written informed consent * Emergency procedure * Pregnancy at time of TAVI Critieria for long-term observation (1y-10y): * Technical success at exit from procedure room (VARC-3): * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication * Absence of the following severe procedural and in-hospital complications (VARC-3 definitions): * All stroke * Bleeding type 3-4 * Myocardial infarction * Need for a second valve * Valve embolization * Coronary obstruction * Annular rupture

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis heart valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic insufficiency Aortic stenosis Degenerative valve disease Transcatheter aortic valve replacement (TAVR)

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

  • Heart and Diabetes Center North Rhine-Westphalia

    RECRUITING

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

More trials for these conditions

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