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

NCT06818006 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis
  • Severe Aortic Stenosis

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

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06818006 on ClinicalTrials.gov