Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT06818006
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.
Detailed Description:
Primary Objectives:
The primary efficacy objective is to determine whether a Transcatheter Aortic Valve Implantation (TAVI) procedure performed by experienced operators in centers without on-site cardiac surgery is non-inferior to a TAVI procedure performed by experienced operators in centers with on-site cardiac surgery in terms of all-cause death, myocardial infarction, stroke and hospitalization for heart failure. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery (ECS) did not differ between study arms.
Research method/Procedures
ATLAS is an all-comer, prospective, randomized, multicenter, open label trial with blinded adjudicated evaluation of outcomes. The ATLAS study will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI. Participants will be recruited after Heart Team discussion and approval for TAVI. The eligibility of each participant will be confirmed by an established multidisciplinary Heart Team. Once approved for TAVI, dedicated review of the ATLAS study inclusion and exclusion criteria will occur. Study patients meeting inclusion and having no exclusion criteria will be randomized in a 2:1 fashion to TAVI performed in the experimental or standard of care arm stratified by two groups: 1) inoperable/high risk and 2) intermediate/low risk.
Randomization:
EXPERIMENTAL 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 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
Schedule of events:
1\. Pre-eligibility screening 2. Inclusion/Exclusion criteria review 3. Randomization 4. 1-month post randomization 5. 3-months post randomization 6. TAVI procedure hospitalization 7. 1-month visit after TAVI 8. 12-month visit after TAVI 9. Final follow-up visit - 12-month post TAVI in control arm and equivalent median time post randomization in the intervention arm
Study:
NCT06818006
Study Brief:
Protocol Section:
NCT06818006