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Less invasive heart valve replacement matches surgery in large trial

NCT ID NCT01586910

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 large study compared two treatments for severe aortic stenosis (a narrowed heart valve) in 1,746 patients at intermediate risk for surgery. One group got a less invasive procedure called TAVI (a new valve inserted through a tube in the artery), and the other had open-heart surgery to replace the valve. The study tracked deaths, strokes, and other heart problems to see if TAVI is a safe alternative to surgery for these patients.

What this could mean

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

Active substance
Medtronic CoreValve® System (transcatheter aortic valve implant) and surgical aortic valve replacement
What this could lead to
If successful, this could confirm that a less invasive valve replacement (TAVI) is as safe and effective as open-heart surgery for intermediate-risk patients, offering a quicker recovery option.
What could go wrong
This is a completed trial (not recruiting) and results are already known. The main risks include stroke, death, and need for reintervention with either approach. Individual outcomes vary.

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

1,746 people

The number who actually took part.

Started

Apr 2012

Expected to finish

Nov 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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and \<15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation; * Heart Team unanimously agree on treatment proposal and eligibility for randomization\* based on their clinical judgement (including anatomy assessment, risk factors, etc.); * Subject has severe aortic stenosis presenting with; 1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND 2. Mean gradient \> 40mmHg or Vmax \> 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization \[or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25; * Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater; * Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits; * Subject meets the legal minimum age to provide informed consent based on local regulatory requirements; Exclusion Criteria: * Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm) * Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve); * A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated; * Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy; * Ongoing sepsis, including active endocarditis; * Any condition considered a contraindication to extracorporeal assistance; * Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization\* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe); * Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\*; * Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; * Recent (within 6 months of randomization\*) cerebrovascular accident (CVA) or transient ischemic attack (TIA); * Active gastrointestinal (GI) bleeding that would preclude anticoagulation; * Subject refuses a blood transfusion; * Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits); * Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned); * Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions; * Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams; * Currently participating in an investigational drug or another device trial (excluding registries); * Evidence of an acute myocardial infarction ≤30 days before the index procedure; * Need for emergency surgery for any reason; * True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR); * Extensive mediastinal radiation; * Liver failure (Child-C); * Reduced ventricular function with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram; * Uncontrolled atrial fibrillation (e.g. resting heart rate \> 120 bpm); * Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements; * End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min; * Pulmonary Hypertension (systolic pressure\> 80mmHg); * Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc; * Frailty assessments identify: 1. Subject is \< 80 years of age and three or more of the following apply 2. Subject is ≥ 80 years of age and two or more of the following apply * Wheelchair bound * Resides in an institutional care facility (e.g., nursing home, skilled care center) * Body Mass Index \< 20 kg/m2 * Grip Strength \< 16 kg * Katz Index Score ≤ 4 * Albumin \< 3.5 g/dL; * Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm) Note: Additional anatomical and vascular exclusion criteria may apply. Note: \* For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Severe aortic stenosis

Contacts and locations

Locations

  • Abbott NW - MN Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Alegent Creighton Health Research Center

    Omaha, Nebraska, 68124, United States

  • Amphia Hospital Breda

    Breda, Netherlands

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006, United States

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226, United States

  • Bern University Hospital

    Bern, Switzerland

  • Beth Israel Deaconess Medical Center, Inc.

    Boston, Massachusetts, 02215, United States

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Carolinas HealthCare System

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    Hollywood, California, 90048, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cooper University Hospital

    Camden, New Jersey, 08103, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Detroit Medical Center

    Detroit, Michigan, 48201-2018, United States

  • Deutsches Herzzentrum Muenchen

    Munich, Germany

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • El Camino Hospital

    Mountain View, California, 94040, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Erasmus Medical Center - Rotterdam

    Rotterdam, Netherlands

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Glenfield Hospital, Leicester, UK

    Leicester, LE5 4PW, United Kingdom

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Henry Ford

    Detroit, Michigan, 48202, United States

  • Hospital Universitario Central de Asturias

    Oviedo, Spain

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Iowa Heart Center / Mercy Medical Center

    West Des Moines, Iowa, 50266, United States

  • Karolinska Universitetssjukhuset Stockholm

    Stockholm, 171 76, Sweden

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • Leeds General Infirmary

    Leeds, United Kingdom

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • London Health Sciences Centre, University Hospital

    London, Ontario, Canada

  • Loyola University of Chicago

    Maywood, Illinois, 60153, United States

  • Mayo Clinic - St. Mary's Hospital

    Rochester, Minnesota, 55905, United States

  • McGill University Health Center - Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1, Canada

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Montreal Heart Institute

    Montreal, Canada

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • New York University School of Medicine

    New York, New York, 10016, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Oklahoma Heart Institute

    Oklahoma City, Oklahoma, 73120, United States

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043, United States

  • Rigshospitalet

    Copenhagen, Denmark

  • Saint Luke's Hospital/MAHI

    Kansas City, Missouri, 64111, United States

  • Scripps Green Hospital

    La Jolla, California, 92037, United States

  • Sentara Cardiovascular

    Norfolk, Virginia, 23507, United States

  • Servicio de Cardiologia del Hospital Virgen de la Victoria

    Málaga, Spain

  • Southern California Permenente Medical Group

    Pasadena, California, 91101, United States

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503, United States

  • St. Antonius Hospital, R & D Cardiology

    Nieuwegein, Netherlands

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. George's Hospital London

    London, SW170QT, United Kingdom

  • St. John Hospital & Medical Center

    Detroit, Michigan, 48236, United States

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Stern Cardiovascular

    Memphis, Tennessee, 38120, United States

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5, Canada

  • The Heart Hospital - Baylor Plano

    Plano, Texas, 75093, United States

  • The Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • The Methodist DeBakey Heart & Vascular Center

    Houston, Texas, 77030, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The OhioHealth Research Institute

    Columbus, Ohio, 43214, United States

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • Toronto General Hospital (University Health Network)

    Toronto, Ontario, M5G 2C4, Canada

  • Universitatsspital Zurich

    Zurich, Switzerland

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • University of Miami

    Coral Gables, Florida, 33146, United States

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-5864, United States

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Vermont

    Burlington, Vermont, 05401, United States

  • Universitäts-Herzzentrum Freiburg • Bad Krozingen

    Bad Krozingen, 79106, Germany

  • Universitätsklinikum Bonn

    Bonn, Germany

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Washington Hospital Center

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

  • Winthrop University Hospital

    Mineola, New York, 11501, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520-8047, United States

More trials for these conditions

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