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

Launched by UNIVERSITY OF ALBERTA · Feb 7, 2025

Keywords

ClinConnect Summary

The ATLAS Study is a clinical trial aimed at understanding whether the Transcatheter Aortic Valve Replacement (TAVR) procedure can be safely performed in hospitals that do not have on-site cardiac surgery available. TAVR is a less invasive procedure used to treat severe aortic stenosis, a condition where the heart's aortic valve narrows, making it hard for blood to flow. Currently, patients typically receive this treatment only in hospitals where surgical backup is readily available. The researchers want to find out if it is just as safe and effective to perform TAVR in experienced centers without immediate surgical support.

To participate in this study, patients must have severe aortic stenosis and be evaluated by a specialized Heart Team for the TAVR procedure. They will need to provide informed consent and be willing to follow up for one year after the procedure. However, certain patients may not be eligible, such as those with specific heart or vascular issues that could complicate the procedure. This study is important because, if successful, it could expand access to TAVR for patients who might benefit from it but live in areas without immediate surgical resources. Participants can expect to receive expert care throughout the trial and will help contribute to valuable research that could improve treatment options for many patients facing similar heart conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team
• • Obtained informed consent
• Exclusion Criteria:
• • 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