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New heart valve registry tracks Long-Term performance

NCT ID NCT07120048

Knowledge-focused Sponsor: Edwards Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study is tracking 500 people who receive the INSPIRIS RESILIA aortic valve during surgery. Researchers will measure how well the valve works by checking blood flow and leakage over time. The goal is to see how the valve performs 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
Edwards INSPIRIS RESILIA Aortic Valve (a surgical heart valve replacement device)
What this could lead to
If successful, this registry will provide real-world data on how well the INSPIRIS RESILIA valve performs, helping doctors make better treatment decisions for patients needing aortic valve replacement.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient differences and may not apply to all populations.

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

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects from Germany who meet all the study inclusion criteria and none of the study exclusion criteria who undergo an aortic valve replacement with the Model 11500A heart valve and voluntary sign a consent form to agree to participate in the study.

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. Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose 2. Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available 3. Age ≥ 18 years 4. Provision of written informed consent Exclusion Criteria: 1. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery 2. Emergency procedure 3. Patients requiring a non-aortic heart valve procedure during the index procedure

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder

As listed by the trial registrant

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

Aortic valve disease

How to take part

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

  1. The places running it

    14 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

  • Deutsches Herzzentrum der Charité Berlin

    RECRUITING

    Berlin, Germany

  • Helios Universitätsklinikum Wuppertal

    RECRUITING

    Wuppertal, North Rhine-Westphalia, Germany

  • Herz- und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, North Rhine-Westphalia, Germany

  • Herzzentrum Dresden

    RECRUITING

    Dresden, Saxony, Germany

  • Herzzentrum Leipzig

    RECRUITING

    Leipzig, Saxony, Germany

  • Klinikum Oldenburg

    RECRUITING

    Oldenburg, Lower Saxony, Germany

  • Klinikum Passau

    RECRUITING

    Passau, Bavaria, Germany

  • LMU Klinikum München

    RECRUITING

    Munich, Bavaria, Germany

  • Rhön Klinikum Campus Bad Neustadt

    RECRUITING

    Bad Neustadt an der Saale, Bavaria, Germany

  • TUM Klinikum Deutsches Herzzentrum

    RECRUITING

    Munich, Bavaria, Germany

  • UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, Germany

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, Bavaria, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, Germany

  • Universitätsklinikum Jena

    RECRUITING

    Jena, Thuringia, Germany

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