Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
ATLAS
1 other identifier
interventional
600
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2026
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
February 10, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
January 7, 2026
January 1, 2026
4.8 years
January 15, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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).
From enrolment to the end of 90 day follow up
Death
Primary Efficacy Outcome: Composite of All Cause death from randomization.
From enrolment to the end of 90 day follow up
Myocardial Infarction
Primary Efficacy Outcome: Composite of All Cause myocardial infarction (MI) from randomization.
From enrolment to the end of 90 day follow up
Stroke
Primary Efficacy Outcome: Composite of All Cause Stroke, from randomization.
From enrolment to the end of 90 day follow up
Heart Failure Hospitalization
Primary Efficacy Outcome: Composite of All Cause Heart Failure Hospitalization from randomization.
From enrolment to the end of 90 day follow up
Secondary Outcomes (17)
Individual components of primary efficacy outcome
From enrolment to the end of 90 day follow up
Hospitalization for cardiovascular cause
From enrolment to the end of 90 day follow up
Permanent Pace Maker (PPM)
From enrolment to the end of 90 day follow up
Urgent percutaneous coronary revascularization
From enrolment to the end of 90 day follow up
Acute kidney injury
From enrolment to the end of 90 day follow up
- +12 more secondary outcomes
Study Arms (2)
Experimental Arm
ACTIVE COMPARATOREXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY After randomization, the participant will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff.
Control Arms
ACTIVE COMPARATORCONTROL ARM: TAVI WITH ON-SITE SURGERY After randomization, the patient will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff at an established TAVI center with on-site cardiac surgery
Interventions
Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight
Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
Eligibility Criteria
You may qualify if:
- Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team
- Obtained informed consent
You may not qualify if:
- 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
- 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
- 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)
- GFR \<15, excluding patients on dialysis
- Life expectancy less than 3 years
- Any factor precluding 1-year follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Mazankowski Heart Insitute
Edmonton, Alberta, T6G 2B7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- blinded clinical events adjudicated
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2025
First Posted
February 10, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
January 7, 2026
Record last verified: 2026-01