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ACTIVE NOT RECRUITING

NCT02701283

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Sponsor: Medtronic Cardiovascular

View on ClinicalTrials.gov

Summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Official title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

2223

Start Date

2016-03

Completion Date

2029-06

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Aortic Valve Stenosis

Interventions

DEVICE

Medtronic Transcatheter Aortic Valve Replacement Systems

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

DEVICE

Surgical Aortic Valve Replacement (SAVR)

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

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.

Locations (87)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Scripps Memorial Hospital La Jolla

La Jolla, California, United States

University of Southern California University Hospital

Los Angeles, California, United States

El Camino Hospital

Mountain View, California, United States

Mercy General Hospital

Sacramento, California, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Morton Plant Hospital

Clearwater, Florida, United States

Delray Medical Center

Delray Beach, Florida, United States

HealthPark Medical Center

Fort Myers, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Tallahassee Research Institute, Inc.

Tallahassee, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

Saint Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Mercy Medical Center

Des Moines, Iowa, United States

The University of Kansas Hospital

Kansas City, Kansas, United States

Jewish Hospital

Louisville, Kentucky, United States

Terrebonne General Medical Center

Houma, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Saint John Hospital and Medical Center

Detroit, Michigan, United States

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mercy Hospital

Springfield, Missouri, United States

Saint Francis Hospital

East Hills, New York, United States

Saint Joseph's Hospital Health Center

Liverpool, New York, United States

Northwell Health

Manhasset, New York, United States

The Mount Sinai Hospital

New York, New York, United States

Strong Memorial Hospital

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Sanford Medical Center

Fargo, North Dakota, United States

Good Samaritan Hospital

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Oregon Health Science University

Portland, Oregon, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Geinsinger Medical Center

Danville, Pennsylvania, United States

Pinnacle Health

Harrisburg, Pennsylvania, United States

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Paramount Heart

Villanova, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, United States

Baylor Saint Luke's Medical Center

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Methodist Hospital San Antonio

San Antonio, Texas, United States

University Hospital Salt Lake City Utah

Salt Lake City, Utah, United States

The University of Vermont Medical Center

Burlington, Vermont, United States

Saint Mary's Hospital

Richmond, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Saint Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital (FSH)

Murdoch, Western Australia, Australia

London Health Sciences Centre

London, Ontario, Canada

Toronto General Health Hospital

Toronto, Ontario, Canada

Glen Royal Victoria (McGill)

Montreal, Quebec, Canada

IUCPQ

Québec, Quebec, Canada

Montreal Heart

Montreal, Canada

Sunnybrook Health Sciences Centre

Toronto, Canada

Centre Hospitalier Régional Universitaire de Lille

Lille, France

L'Hôpital Privé Jacques Cartier Massy

Massy, France

Clinique Pasteur

Toulouse, France

Kokura Memorial Hospital

Kitakyushu, Fokuoka, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Teikyo University Hospital

Tokyo, Itabashi-Ku, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

National Cerebral and Cardiovasclular Center

Suita, Osaka, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Catharina Ziekenhuis

Eindhoven, Netherlands

St. Antonius Hospital Nieuwegein

Nieuwegein, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Waikato Hospital

Hamilton, New Zealand

Clinical Research Directory

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (87)