Last updated on April 2019

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Brief description of study

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.

Detailed Study Description

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.

Clinical Study Identifier: NCT02701283

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Mercy General Hospital

Sacramento, CA United States
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Los Robles Hospital & Medical Center

Thousand Oaks, CA United States
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Yale New Haven Hospital

New Haven, CT United States
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Morton Plant Hospital

Clearwater, FL United States
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Delray Medical Center

Delray Beach, FL United States
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HealthPark Medical Center

Fort Myers, FL United States
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Piedmont Atlanta Hospital

Atlanta, GA United States
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Mercy Medical Center

Des Moines, IA United States
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The University of Kansas Hospital

Kansas City, KS United States
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Jewish Hospital

Louisville, KY United States
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The Johns Hopkins Hospital

Baltimore, MD United States
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Spectrum Health Hospitals

Grand Rapids, MI United States
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Abbott Northwestern Hospital

Minneapolis, MN United States
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Mercy Hospital

Springfield, MO United States
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Saint Francis Hospital

East Hills, NY United States
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The Mount Sinai Hospital

New York, NY United States
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Strong Memorial Hospital

Rochester, NY United States
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Wake Forest Baptist Medical Center

Winston-Salem, NC United States
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Sanford Medical Center

Fargo, ND United States
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Good Samaritan Hospital

Cincinnati, OH United States
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The Ohio State University

Columbus, OH United States
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Integris Baptist Medical Center

Oklahoma City, OK United States
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Lehigh Valley Hospital

Allentown, PA United States
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Geinsinger Medical Center

Danville, PA United States
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Pinnacle Health

Harrisburg, PA United States
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Houston Methodist Hospital

Houston, TX United States
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Saint Mary's Hospital

Richmond, VA United States
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Winchester Medical Center

Winchester, VA United States
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Swedish Medical Center

Seattle, WA United States
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El Camino Hospital

Mountain View, CA United States
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Baystate Medical Center

Springfield, MA United States
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Northwell Health

Manhasset, NY United States
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Methodist Hospital San Antonio

San Antonio, TX United States
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The Alfred Hospital

Melbourne, Australia
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Quebec, QC Canada
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Catharina Ziekenhuis

Eindhoven, Netherlands
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Waikato Hospital

Hamilton, New Zealand
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Montreal Heart

Montréal, Canada
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Recruitment Status: Open

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