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New heart valve trial offers hope for thousands with stiff heart valves

NCT ID NCT05932615

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 trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study tests a new device called the Navitor TAVI system to replace a stiff, narrowed heart valve without open-heart surgery. It includes 1,500 people with severe aortic stenosis who are at low or intermediate risk for surgery. The goal is to see if the device is safe and effective at improving blood flow and reducing complications like stroke or death.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,500 people

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

Started

Mar 2024

Expected to finish

Apr 2036

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.

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.

Key Inclusion Criteria: 1. Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement: 1. Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and \< 8% at 30 days 2. Low risk: estimated risk of overall surgical mortality \< 3% at 30 days Estimated risk of overall surgical mortality includes consideration of the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator 2. New York Heart Association (NYHA) Functional Classification of II, III, or IV 3. Degenerative aortic valve stenosis Key Exclusion Criteria: 1. In the opinion of the Investigator, life expectancy is less than 2 years 2. Evidence of an acute myocardial infarction \[defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation\] within 30 days prior to index procedure 3. Untreated clinically significant coronary artery disease requiring revascularization 4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure 5. Blood dyscrasias as defined: leukopenia (WBC \< 3000 mm3), acute anemia (Hb \< 9 g/dL), thrombocytopenia (platelet count \< 50,000 cells/mm³); history of bleeding diathesis or coagulopathy 6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation 7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA) 8. Renal insufficiency (creatinine \> 3.0 mg/dL or eGFR \< 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis 9. Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.) 10. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk 11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+) 12. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT. 13. Severe ventricular dysfunction with LVEF \< 30% as measured by resting echocardiogram 14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position 15. Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT) 16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis 17. Minimum access vessel diameter of \< 5.0 mm for small FlexNav Delivery System and \< 5.5 mm for large FlexNav Delivery System 18. Eccentricity ratio of the annulus \< 0.73 Additional Exclusion Criteria for Pivotal Randomized Cohort 1. Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk 2. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk 3. Mixed aortic valve disease 4. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT 5. Inadequate aortic valve calcification 6. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position Additional Exclusion Criteria for ViV Cohort 1. Failing valve has moderate or greater paravalvular regurgitation. 2. Known severe prosthesis-patient mismatch 3. Failing valve is unstable, rocking, or not structurally intact. 4. Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic. 5. Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve. 6. Increased risk of coronary obstruction by prosthetic leaflets of the index valve Additional Exclusion Criteria for bicuspid cohort 1. In the opinion of the Investigator life expectancy is less than 1 year 2. Inadequate or severe aortic valve calcification and/or anatomical features that would preclude safe delivery of the valve

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder aortic valve stenosis cardiovascular disorder heart disorder heart valve disorder

As listed by the trial registrant

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

Aortic valve disease Aortic valve stenosis Heart disease structural disorder Heart valve diseases

How to take part

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

  1. The places running it

    107 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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 Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • AZORG

    Aalst, Eflndrs, Belgium

  • AdventHealth Orlando

    Orlando, Florida, 32825, United States

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania, 15212, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Ascension St. Vincent

    Indianapolis, Indiana, 46290, United States

  • Ascension Texas Cardiovascular

    Austin, Texas, 78705, United States

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67226, United States

  • AtlantiCare Regional Medical Center - Mainland Campus

    Pomona, New Jersey, 08240, United States

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215, United States

  • Austin Heart

    Austin, Texas, 78756, United States

  • Baptist Hospital of Miami

    Miami, Florida, 33176, United States

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120, United States

  • Basel University Hospital

    Basel, 4031, Switzerland

  • Baylor Scott & White - The Heart Hospital Plano

    Plano, Texas, 75093, United States

  • CHU Rennes, Pontchaillou

    Rennes, Brittan, 35033, France

  • Clinique Pasteur Toulouse

    Toulouse, Midpyre, 31076, France

  • Columbia University Medical Center/NYPH

    New York, New York, 10032, United States

  • East Carolina Heart Institute

    Greenville, North Carolina, 27834, United States

  • Endeavor Health

    Evanston, Illinois, 60201, United States

  • Englewood Hospital & Medical Center

    Englewood, New Jersey, 076960, United States

  • Freeman Hospital

    Newcastle upon Tyne, United Kingdom

  • HCA Florida - JFK Hospital

    Atlantis, Florida, 33462, United States

  • HCA Florida Largo Hospital

    Largo, Florida, 33770, United States

  • HCA Florida Ocala Hospital

    Ocala, Florida, 34471, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hillcrest Medical Center

    Tulsa, Oklahoma, 74104, United States

  • Hopital Haut Leveque

    Pessac, AQT, 33600, France

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, H1T 1C8, Canada

  • Intermountain Health St George Regional Hospital (Main Campus and IMC Murray)

    St. George, Utah, 84790, United States

  • John Hunter Hospital

    Newcastle, New South Wales, 2300, Australia

  • Kaiser Permanente Fontana Medical Center

    Fontana, California, 92335, United States

  • Karolinska University Hospital, Solna

    Stockholm, Sweden

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, Germany

  • King's College Hospital

    London, United Kingdom

  • Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt

    Frankfurt, Germany

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096, United States

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360, United States

  • MUHC - The Royal Victoria Hospital

    Montreal, Quebec, H4A3J1, Canada

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medizinische Einrichtungen der Universität zu Koln

    Cologne, Germany

  • Mission Hospital

    Asheville, North Carolina, 28801, United States

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Montefiore Medical Center (Main Campus and White Plains Hospital)

    New York, New York, 10467, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07962, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • MyMichigan Medical Center Midland

    Midland, Michigan, 48670, United States

  • Naples Comprehensive Health

    Naples, Florida, 34102, United States

  • North Central Heart

    Sioux Falls, South Dakota, 57108, United States

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501, United States

  • Northwestern Memorial Hospital

    Evanston, Illinois, 60201, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43113, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health System

    Mechanicsburg, Pennsylvania, 17055, United States

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Rabin Medical Center

    Petah Tikva, Israel

  • Rigshospitalet

    Copenhagen, Denmark

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Royal Adelaide Hospital

    Adelaide, Saustrl, 5000, Australia

  • Sahlgrenska University Hospital - Gothenburg

    Gothenburg, Sweden

  • Saint John Regional Hospital - New Brunswick Heart Centre

    Saint John, NB E2L 4L4, Canada

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Shaare Zedek Medical Center

    Jerusalem, Jeruslm, 9103102, Israel

  • Southern California Permanente Medical Group - La Jolla

    La Jolla, California, 92037, United States

  • St. Bartholomew's Hospital

    London, United Kingdom

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona, 85013, United States

  • St. Joseph's Hospital & Medical Center

    Denver, Colorado, 80218, United States

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, V6E 1M7, Canada

  • St.-Johannes Hospital

    Dortmund, N. RHIN, 44137, Germany

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • TUM Klinikum - Deutsches Herzzentrum Munchen

    München, Germany

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • The Queen's Medical Center

    Honolulu, Hawaii, 96814, United States

  • The Royal Sussex County Hospital

    Brighton, United Kingdom

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Tucson Medical Center

    Tucson, Arizona, 85712, United States

  • UTHealth Memorial Hermann

    Houston, Texas, 77030, United States

  • Universitair Medisch Centrum Groningen

    Groningen, Grogen, 9713 GZ, Netherlands

  • Universitatsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Germany

  • Universitatsklinikum Ulm

    Ulm, Germany

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35233, United States

  • University of California at San Francisco

    San Francisco, California, 94143, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Virginia Medical Center (Main Campus and Riverside Regional Medical Center Location)

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virtua Our Lady of Lourdes Hospital

    Camden, New Jersey, 08103, United States

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Western Michigan Univ. Homer Stryker M.D. School of Medicine

    Kalamazoo, Michigan, 49048, United States

More trials for these conditions

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