Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study) (NCT06818006)
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Royal Alexandra Hospital β Edmonton, Alberta
Age range: 18 Years
π§ͺ Interventions in This Study
- Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight (PROCEDURE)
- Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight (PROCEDURE)
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (2 Sites)
- Royal Alexandra Hospital β Edmonton, Alberta
- Mazankowski Heart Insitute β Edmonton, Alberta
π Contact the Study Coordinator
Phone: (780) 407-2685
Email: Robert.Welsh@albertahealthservices.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Aortic Stenosis
- PERIGON Pivotal Trial β Los Angeles, California
- ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement β Birmingham, Alabama
- PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis β Birmingham, Alabama
- Use of DurAVRβ’ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study β Tucson, Arizona
- Systematic Ambulatory ECG Monitoring Following TAVI β QuΓ©bec, Quebec
Explore by condition: All Aortic Stenosis clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.