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Study identifier: NCT05932615 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Enrolling By Invitation

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

Condition: Aortic Valve Stenosis · Heart Valve Diseases · Aortic Valve Disease  ·  Sponsor: Abbott Medical Devices

PhaseNA
Planned participants1500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk. In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (84)

University Hospital - Univ. of Alabama at Birmingham (UAB)Birmingham, Alabama, United States
St. Joseph's Hospital & Medical CenterPhoenix, Arizona, United States
Tucson Medical CenterTucson, Arizona, United States
Arkansas Heart HospitalLittle Rock, Arkansas, United States
Kaiser Permanente Fontana Medical CenterFontana, California, United States
Southern California Permanente Medical Group - La JollaLa Jolla, California, United States
University of California at San FranciscoSan Francisco, California, United States
Stanford University Medical CenterStanford, California, United States
Los Robles Regional Medical CenterThousand Oaks, California, United States
St. Joseph's Hospital & Medical CenterDenver, Colorado, United States
Washington Hospital CenterWashington D.C., District of Columbia, United States
HCA Florida - JFK HospitalAtlantis, Florida, United States

+ 72 more locations — full list on the registry record.

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