Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
Qualifiers
Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team
Obtained informed consent
Disqualifiers
Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization
High risk LVOT with a dimension significantly smaller than the annulus and/or extensive calcification
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)
High risk STJ anatomy defined by inadequate height and/or diameter and/or excessive calcification
Trial design
Treatments tested in this trial
- Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight
- Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov