Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Alberta
- Trial code
- NCT06818006
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery
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.
Inclusion: Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team; Obtained informed consent.
Exclusion: Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and/or shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG); GFR <15, excluding patients on dialysis; Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization; Hostile aortic root on CT for TAVI implantation defined by, but not limited to:; High risk LVOT with a dimension significantly smaller than the annulus and/or extensive calcification; High risk STJ anatomy defined by inadequate height and/or diameter and/or excessive calcification; Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and/or unfolded aorta and/or extensive tortuosity and/or excessive iliofemoral calcification); Life expectancy less than 3 years; Any factor precluding 1-year follow-up.