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New heart valve study aims to improve treatment for aortic stenosis

NCT ID NCT06008080

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study is testing the safety and performance of the Navitor TAVI system, a device used to replace a narrowed heart valve (aortic stenosis) without open-heart surgery. About 1,000 participants who are eligible for the procedure will receive the Navitor valve and be followed for 30 days to check for death from any cause and for leakage around the new valve. The goal is to see how well the device works in a real-world setting.

What this could mean

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

Active substance
Navitor Transcatheter Aortic Valve
What this could lead to
If successful, this study could confirm the Navitor valve as a safe and effective option for treating aortic stenosis, potentially improving outcomes for many patients.
What could go wrong
This is a post-market study, so the device is already approved; however, risks include complications from the procedure such as death, paravalvular leak, or other adverse events.

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

Sep 2023

Expected to finish

Jun 2032

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

This study will enroll subjects of all genders from the population of patients qualifying for TAVI.

Ages

18 to 100 years

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: * Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure. * The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the IRB (Investigational Review Board)/EC (Ethics Committee) of the respective clinical site. * The patient and the treating physician agree that the subject will return for all required post procedure follow up visits. Exclusion Criteria: * Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU) * Life expectancy \< 12 months from the time of informed consent due to non-cardiac co-morbid conditions. * In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study. * Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. * Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated. * Currently participating in an investigational drug or device study that may confound the results of this study * Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiovascular disorder

As listed by the trial registrant

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

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

    44 sites in 11 countries. 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

  • Az. Osp. Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy

  • CHRU Hopital de Pontchaillou

    RECRUITING

    Rennes, France

  • CHU Pointchaillou Rennes

    RECRUITING

    Rennes, France

  • Casa di Cura Pineta Grande

    RECRUITING

    Castel Volturno, Italy

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, Italy

  • Clinique Pasteur Toulouse

    RECRUITING

    Toulouse, France

  • Clinique du Millénaire

    RECRUITING

    Montpellier, France

  • Consorcio Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Deutsches Herzzentrum München des Freistaates Bayern

    RECRUITING

    München, Germany

  • Deutsches Herzzentrum der Charité

    ACTIVE_NOT_RECRUITING

    Berlin, Germany

  • HCU Virgen de la Victoria

    RECRUITING

    Málaga, Spain

  • Herz- u. Gefäßzentrum Bad Bevensen

    RECRUITING

    Bad Bevensen, Germany

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital General Juan Ramon Jimenez

    RECRUITING

    Huelva, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Majadahonda, Spain

  • Hospital Universitario de Badajoz

    ACTIVE_NOT_RECRUITING

    Badajoz, Spain

  • Hospital de Gran Canaria Doctor Negrín

    RECRUITING

    Las Palmas, Spain

  • Hospital de la Santa Creu I Sant Pau

    RECRUITING

    Barcelona, Spain

  • IRCCS ISMETT - Palermo

    RECRUITING

    Palermo, Italy

  • Institute Cardio. Paris-Sud - Institut Jacques Cartier

    RECRUITING

    Massy, France

  • James Cook University Hospital

    ACTIVE_NOT_RECRUITING

    Middlesbrough, United Kingdom

  • KS St. Gallen / USZ

    RECRUITING

    Sankt Gallen, Switzerland

  • Kings College Hospital

    RECRUITING

    London, United Kingdom

  • Kliniken der Friedrich-Alexander-Universitat

    RECRUITING

    Erlangen, Germany

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    RECRUITING

    Frankfurt, Germany

  • Leiden University Medical Center

    RECRUITING

    Leiden, Netherlands

  • Medizinische Einrichtungen der Universität zu Köln

    RECRUITING

    Cologne, Germany

  • Mutualiste Montsouris

    RECRUITING

    Paris, France

  • New Cross Hospital

    RECRUITING

    Wolverhampton, United Kingdom

  • Onze Lieve Vrouw Gasthuis

    RECRUITING

    Amsterdam, Netherlands

  • Ospedale San Raffaele - Cardiac

    RECRUITING

    Milan, Italy

  • Ospedale Umberto I di Torino

    RECRUITING

    Torino, Italy

  • Policlinico San Donato

    RECRUITING

    San Donato Milanese, Italy

  • Policlinico Universitario A. Gemelli

    RECRUITING

    Roma, Italy

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, Australia

  • Royal Hobart Hospital

    RECRUITING

    Hobart, Australia

  • Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, United Kingdom

  • Royal Stoke University Hospital

    ACTIVE_NOT_RECRUITING

    Stoke-on-Trent, United Kingdom

  • Sahlgrenska University Hospital - Gothenburg

    RECRUITING

    Gothenburg, Sweden

  • Sheba Medical Center

    RECRUITING

    Tel Litwinsky, Israel

  • St Johannes Hospital Dortmund

    RECRUITING

    Dortmund, Germany

  • St. Thomas Hospital

    RECRUITING

    London, United Kingdom

  • The Alfred Hospital

    RECRUITING

    Melbourne, Australia

  • UKE Hamburg

    ACTIVE_NOT_RECRUITING

    Hamburg, Germany

  • ULS de Lisboa Ocidental

    RECRUITING

    Carnaxide, Portugal

  • ULS de São José

    RECRUITING

    Lisbon, Portugal

  • UMC Utrecht

    RECRUITING

    Utrecht, Netherlands

  • University Hospital Rostock

    ACTIVE_NOT_RECRUITING

    Rostock, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    RECRUITING

    Kiel, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, Germany

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