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New hope for heart patients: less invasive valve procedure tested for moderate stenosis

NCT ID NCT05149755

Disease control Sponsor: Medtronic Cardiovascular 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a less invasive heart valve replacement (TAVR) is safe and effective for people with moderate aortic stenosis, a condition where the heart's aortic valve is partially blocked. About 650 participants will receive the TAVR device and be monitored for complications, survival, and quality of life. The goal is to expand the use of this procedure to help more patients avoid open-heart surgery.

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 650 people

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

Started

Apr 2022

Expected to finish

Dec 2034

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

65 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: o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL: * AVA \>1.0 cm² and \<1.5cm²; or * AVA ≤ 1.0 cm² with AVAI \> 0.6cm²/m² if BMI \< 30 kg/m²: or * AVA ≤ 1.0 cm² with AVAI \> 0.5cm²/m² if BMI ≥ 30 kg/m²: and * Max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or * Mean aortic gradient ≥ 20mmHg and \< 40.0 mmHg Any of the following at-risk features: * Symptoms of AS, defined as: * NYHA ≥ Class II, or * Reduced functional capacity, defined as * 6MWT \< 300 meters, or * \< 85% of age-sex predicted METs on exercise tolerance testing (ETT) * Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent * NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or * Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or * Elevated aortic valve calcium score (\>1200 AU for females and \> 2000 AU for males) as assessed by the MDCT core lab, or * Any of the following by the qualifying TTE as assessed by the ECL: * Global longitudinal strain ≤16% (absolute value), or * E/e' ≥ 14.0 (average of medial and lateral velocities), or * Diastolic dysfunction ≥ Grade II, or * LVEF \< 60% * Stroke Volume Index \< 35 ml/m² * Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system * The subject and the treating physician agree the subject will return for all required follow-up visits Key Exclusion Criteria: * Age \< 65 years * LVEF ≤ 20% by 2-D echo * Class I indication for cardiac surgery * Contraindication for placement of a bioprosthetic valve * Documented history of cardiac amyloidosis

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Constriction, Pathologic follicular lymphoma

As listed by the trial registrant

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

Moderate aortic valve stenosis

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Abrazo Arizone Heart Hospital

    Phoenix, Arizona, 85016, United States

  • Allgemeines Krankenhaus - Universitätskliniken Wien

    Vienna, 1030, Austria

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236, United States

  • Aurora Saint Lukes Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHRU Brest - Hôpital de la Cavale Blanche

    Brest, 29609, France

  • CHU de Liege- Hopital du Sart Tilman

    Liège, 4000, Belgium

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, Brittany Region, France

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014, United States

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007, Spain

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015, United States

  • Englewood Hospital & Medical Center

    Englewood, New Jersey, 076931, United States

  • Erasmus MC

    Rotterdam, 3015, Netherlands

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403, United States

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • Galway University Hospitals - University Hospital Galway (UHG)

    Galway, H91 YR71, Ireland

  • Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289, Germany

  • HonorHealth Scottsdale Shea Medical Center

    Scottsdale, Arizona, 85260, United States

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47006, Spain

  • Hospital Universitari Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097, Italy

  • Inselspital - Universitätsspital Bern

    Bern, 3010, Switzerland

  • Institut Médico-Chirurgical Montsouris

    Paris, 75014, France

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

    Québec, Quebec, G1V 4G5, Canada

  • Intermountain Cardiovascular and Thoracic Surgery

    Salt Lake City, Utah, 84111, United States

  • Jewish Hospital

    Louisville, Kentucky, 40202, United States

  • Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund

    Dortmund, 44137, Germany

  • Kawasaki Saiwai Hospital

    Kawasaki, Kanagawa, 212-0014, Japan

  • Kettering Health Main Campus

    Kettering, Ohio, 45429, United States

  • Klinikum der Universität München - Campus Grosshadern

    München, 15, 81377, Germany

  • Lehigh Valley Hospital, Inc

    Allentown, Pennsylvania, 18103, United States

  • London Health Sciences Centre- University Campus

    London, Ontario, N6C 2R5, Canada

  • Los Robles Hospital & Medical Center

    Thousand Oaks, California, 91360, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Washington Hospital Center

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

  • Medical City Dallas

    Dallas, Texas, 75230, United States

  • Methodist Hospital San Antonio

    San Antonio, Texas, 78229, United States

  • Mission Hospital

    Asheville, North Carolina, 28801, United States

  • Montreal Heart Hospital

    Montreal, Quebec, H1T1C8, Canada

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota, 57701, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Osaka Keisatsu Hospital

    Osaka, 543-0035, Japan

  • Osaka University Hospital

    Osaka, 565-0871, Japan

  • Ospedale San Raffaele - Milano

    Milan, 20132, Italy

  • Presidio Ospedaliero Gaspare Rodolico

    Catania, 95123, Italy

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington, 99204, United States

  • Queen Elizabeth II Health Sciences Centre

    Halifax, B3H 3A7, Canada

  • Rabin Medical Center- Beilinson Hospital

    Petah Tikva, 49100, Israel

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63110, United States

  • Saint Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • Saint Vincent's Medical Center Riverside

    Jacksonville, Florida, 32204, United States

  • Saint Vincents Medical Center

    Bridgeport, Connecticut, 06606-4201, United States

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shonan Kamakura General Hospital

    Kanagawa, Kamakura, 247-8533, Japan

  • Skanes Universitetssjukhus

    Lund, 22185, Sweden

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • St Antonius Ziekenhuis

    Nieuwegein, 3435, Netherlands

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308-5054, United States

  • Tampa General Hospital

    Tampa, Florida, 33620, United States

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360, United States

  • Texas Health Harris Methodist Hospital Fort Worth

    Fort Worth, Texas, 76104, United States

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of Vermont

    Burlington, Vermont, 05401-1473, United States

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193, Japan

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UPMC Pinnacle Harrisburg Campus

    Harrisburg, Pennsylvania, 17101, United States

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • University Hospital Sankt Poelten

    Sankt Pölten, 3100, Austria

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106-1716, United States

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35233, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Michigan Health System - University Hospital

    Ann Arbor, Michigan, 48109-1274, United States

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, 79189, Germany

  • Universitätsklinikum Bonn

    Bonn, 53217, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Wake Forest University Heatlh Sciences

    Winston-Salem, North Carolina, 27157, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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