New study: less invasive heart valve procedure as safe as surgery for Low-Risk patients

NCT ID NCT02701283

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a less invasive procedure called TAVR (replacing the aortic valve through a tube in an artery) is as safe and effective as open-heart surgery for people with severe aortic stenosis who are otherwise healthy enough for surgery. About 2,200 participants will be randomly assigned to TAVR or surgery, and researchers will track deaths and disabling strokes over two years. The goal is to see if TAVR can be a good alternative to surgery for low-risk patients.

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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

2,223 people

The number who actually took part.

Start date

Mar 2016

Expected to finish

Jun 2029

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: 1. Severe aortic stenosis, defined as follows: 1. For symptomatic patients: Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest 2. For asymptomatic patients: * Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR * Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR * Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%. 2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR \<3% at 30 days per multidisciplinary local heart team assessment. 3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. Exclusion Criteria: 1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve). 2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated: 1. aspirin or heparin (HIT/HITTS) and bivalirudin 2. ticlopidine and clopidogrel 3. Nitinol (titanium or nickel) 4. contrast media 3. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states. 4. Ongoing sepsis, including active endocarditis. 5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization. 6. Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery. 7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment. 8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 10. Gastrointestinal (GI) bleeding that would preclude anticoagulation. 11. Subject refuses a blood transfusion. 12. 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). 13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions. 14. 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. 15. Currently participating in an investigational drug or another device trial (excluding registries). 16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria). 17. Need for emergency surgery for any reason. 18. Subject is pregnant or breast feeding. 19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable 20. Pre-existing prosthetic heart valve in any position. 21. Severe mitral regurgitation amenable to surgical replacement or repair. 22. Severe tricuspid regurgitation amenable to surgical replacement or repair. 23. Moderate or severe mitral stenosis amenable to surgical replacement or repair. 24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient. 25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI. 26. Prohibitive left ventricular outflow tract calcification. 27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis. 28. Aortic annulus diameter of \<18 or \>30 mm. 29. Significant aortopathy requiring ascending aortic replacement. For transfemoral or transaxillary (subclavian) access: 30. Access vessel mean diameter \<5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter \<5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<6.0 mm for the Evolut 34R or Evolut PRO TAV.

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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.

Aortic valve stenosis

Contacts and locations

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States
Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, 75204, United States
Baylor Saint Luke's Medical Center

Houston, Texas, 77030, United States
Baystate Medical Center

Springfield, Massachusetts, 01199, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Catharina Ziekenhuis

Eindhoven, 5623, Netherlands
Centre Hospitalier Régional Universitaire de Lille

Lille, 59000, France
Clinique Pasteur

Toulouse, 31300, France
Delray Medical Center

Delray Beach, Florida, 33484, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
El Camino Hospital

Mountain View, California, 64040, United States
Erasmus Medisch Centrum

Rotterdam, 3015, Netherlands
Fiona Stanley Hospital (FSH)

Murdoch, Western Australia, 6150, Australia
Geinsinger Medical Center

Danville, Pennsylvania, 17043, United States
Glen Royal Victoria (McGill)

Montreal, Quebec, H4A 3J1, Canada
Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States
HealthPark Medical Center

Fort Myers, Florida, 33908, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
IUCPQ

Québec, Quebec, G1V 4G5, Canada
Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States
Jewish Hospital

Louisville, Kentucky, 40202, United States
Kokura Memorial Hospital

Kitakyushu, Fokuoka, Japan
L'Hôpital Privé Jacques Cartier Massy

Massy, 91300, France
Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States
London Health Sciences Centre

London, Ontario, N6A 5A5, Canada
Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Mercy General Hospital

Sacramento, California, 95816, United States
Mercy Hospital

Springfield, Missouri, 65806, United States
Mercy Medical Center

Des Moines, Iowa, 50314, United States
Methodist Hospital San Antonio

San Antonio, Texas, 78229, United States
Monash Health

Clayton, Victoria, 3168, Australia
Montreal Heart

Montreal, H1T 1C8, Canada
Morton Plant Hospital

Clearwater, Florida, 33756, United States
National Cerebral and Cardiovasclular Center

Suita, Osaka, Japan
Northwell Health

Manhasset, New York, 11030, United States
OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Oregon Health Science University

Portland, Oregon, 97239, United States
Paramount Heart

Villanova, Pennsylvania, 19085, United States
Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States
Pinnacle Health

Harrisburg, Pennsylvania, 17043, United States
Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia
Saint Francis Hospital

East Hills, New York, 11548, United States
Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States
Saint Joseph's Hospital Health Center

Liverpool, New York, 13088, United States
Saint Mary's Hospital

Richmond, Virginia, 23226, United States
Saint Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States
Saint Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia
Sakakibara Heart Institute

Fuchū, Tokyo, Japan
Sanford Medical Center

Fargo, North Dakota, 58102, United States
Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan
Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States
Sendai Kousei Hospital

Sendai, Miyagi, Japan
Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan
Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States
St. Antonius Hospital Nieuwegein

Nieuwegein, 3435, Netherlands
Strong Memorial Hospital

Rochester, New York, 14642, United States
Sunnybrook Health Sciences Centre

Toronto, Canada
Swedish Medical Center

Seattle, Washington, 98122, United States
Tallahassee Research Institute, Inc.

Tallahassee, Florida, 32308, United States
Teikyo University Hospital

Tokyo, Itabashi-Ku, Japan
Terrebonne General Medical Center

Houma, Louisiana, 70360, 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

Columbus, Ohio, 43210, United States
The University of Kansas Hospital

Kansas City, Kansas, 66160, United States
The University of Osaka Hospital

Suita, Osaka, Japan
The University of Vermont Medical Center

Burlington, Vermont, 05401, United States
Toronto General Health Hospital

Toronto, Ontario, MSG2C4, Canada
University Hospital Salt Lake City Utah

Salt Lake City, Utah, 84132, United States
University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Maryland Medical Center

Baltimore, Maryland, 21201, United States
University of Miami Hospital

Miami, Florida, 33136, United States
University of Michigan Health System

Ann Arbor, Michigan, 48109, United States
University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15232, United States
University of Southern California University Hospital

Los Angeles, California, 90033, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Waikato Hospital

Hamilton, New Zealand
Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States
Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

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