Clinical Trial

Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)

Study acronym: ATLAS
Not Yet Recruiting Phase 4
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-02-07; most recent amendment 2026-06-01.
Trial Details
NCT Number NCT06818006
Lead Sponsor University of Alberta
Conditions Aortic Stenosis, Severe Aortic Stenosis
Enrollment 600 participants
Start Date 2026-08-01
Primary Completion 2030-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-02