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NOT YET RECRUITING
NCT06818006
PHASE4

Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

Official title: Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-03-01

Completion Date

2030-12

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

PROCEDURE

Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight

Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight

PROCEDURE

Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight

Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight

Locations (2)

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Mazankowski Heart Insitute

Edmonton, Alberta, Canada