Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT06818006
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06818006
Study Brief:
Protocol Section:
NCT06818006