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Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Condition: Aortic Valve Stenosis · Sponsor: Medtronic Cardiovascular
About this 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.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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 | — |
+ 75 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02701283