ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Enrolling by invitation · Not applicable
Conditions studied: Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
In brief
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.
Key facts
- Study ID
- NCT05932615
- Run by
- Abbott Medical Devices
- People needed
- 1500
- Starts
- 2024-03-15
- Expected to finish
- 2036-04-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
- Tucson Medical Center — Tucson, Arizona, United States
- Arkansas Heart Hospital — Little Rock, Arkansas, United States
- Kaiser Permanente Fontana Medical Center — Fontana, California, United States
- Southern California Permanente Medical Group - La Jolla — La Jolla, California, United States
- University of California at San Francisco — San Francisco, California, United States
- Stanford University Medical Center — Stanford, California, United States
- Los Robles Regional Medical Center — Thousand Oaks, California, United States
- St. Joseph's Hospital & Medical Center — Denver, Colorado, United States
- Washington Hospital Center — Washington D.C., District of Columbia, United States
- HCA Florida - JFK Hospital — Atlantis, Florida, United States
- HCA Florida Largo Hospital — Largo, Florida, United States
- Baptist Hospital of Miami — Miami, Florida, United States
- HCA Florida Ocala Hospital — Ocala, Florida, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Tallahassee Research Institute — Tallahassee, Florida, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Northeast Georgia Medical Center — Gainesville, Georgia, United States
- The Queen's Medical Center — Honolulu, Hawaii, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Endeavor Health — Evanston, Illinois, United States
- Northwestern Memorial Hospital — Evanston, Illinois, United States
- Ascension St. Vincent — Indianapolis, Indiana, United States
- Via Christi Regional Medical Center - St. Francis Campus — Wichita, Kansas, United States
- University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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