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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight
Procedure/SurgeryTranscatheter Aortic Valve Replacement (TAVR) with surgical oversight
Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
Procedure/SurgeryTranscatheter Aortic Valve Replacement (TAVR) without surgical oversight
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Experimental ArmActive comparator 1 intervention
Group B: Control ArmsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of an Emergent CardiacSurgery (ECS) event: Ventricular
Primary Safety Outcome: Occurrence of an ECS event: Ventricular Valve Embolization, Aortic Annular Rupture, Ventricular Perforation requiring ECS or Ascending Aortic Dissection requiring ECS. Composite Endpoint of Primary Efficacy and Safety (Net clinical benefit) Multiple measurement will result in an outcome of ECS (Emergent Cardiac Surgery).
Time frame
From enrolment to the end of 90 day follow up2
Death
Primary Efficacy Outcome: Composite of All Cause death from randomization.
Time frame
From enrolment to the end of 90 day follow up3
Myocardial Infarction
Primary Efficacy Outcome: Composite of All Cause myocardial infarction (MI) from randomization.
Time frame
From enrolment to the end of 90 day follow up4
Stroke
Primary Efficacy Outcome: Composite of All Cause Stroke, from randomization.
Time frame
From enrolment to the end of 90 day follow upSecondary outcomes
1
Individual components of primary efficacy outcome
Secondary Efficacy Outcome: Individual components of primary efficacy outcome
Time frame
From enrolment to the end of 90 day follow up2
Hospitalization for cardiovascular cause
Secondary Efficacy Outcome: Hospitalization for cardiovascular cause
Time frame
From enrolment to the end of 90 day follow up3
Permanent Pace Maker (PPM)
Secondary Efficacy Outcome: Need for Permanent Pace Maker (PPM) during study period
Time frame
From enrolment to the end of 90 day follow up4
Urgent percutaneous coronary revascularization
Secondary Efficacy Outcome: Need for urgent percutaneous coronary revascularization
Time frame
From enrolment to the end of 90 day follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: