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Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Sponsor: University of Alberta
Summary
The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available. Hypothesis The investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.
Official title: Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-03-01
Completion Date
2030-12
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight
Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight
Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
Locations (2)
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Mazankowski Heart Insitute
Edmonton, Alberta, Canada