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:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03432494
Eligibility Criteria:
* INCLUSION CRITERIA:
* Consents to participate in this study and all related clinical follow-up procedures
* Adults age greater than or equal to 21 years
* Undergoing transcatheter aortic valve replacement (TAVR) based on the clinical assessment of the multidisciplinary heart team
* Ineligible for femoral artery access for the selected transcatheter heart valve (THV) according to the THV manufacturer instructions for use. (Note Corevalve Evolut R: greater than or equal to 5mm; Evolut PRO 23, 26, 29 mm valves and Evolut R 34 mm: greater than or equal to 5.5 mm; Edwards Sapien 3, 23-26mm: 5.5 mm; Edwards Sapien 3, 29mm: 6.0mm; Anatomic ineligibility also considers patient-specific pattern of iliofemoral calcium and tortuosity.)
* Eligible for transcaval access based on Core lab analysis of the baseline abdomen/pelvis CT indicating a calcium-free target window on the abdominal aorta; a target greater than or equal to 15mm from the lowest main renal artery or aorto-iliac bifurcation; no important interposed structures; a projected intravascular centerline distance from the lower femoral head to the target at least 5cm less than the intended THV introducer sheath; patient celiac or superior mesenteric artery
* Aorta diameter greater than or equal to 11mm at the target crossing site
* Concordance of the study eligibility committee
EXCLUSION CRITERIA:
* High risk features on baseline CT including porcelain aorta (confluent calcification); pedunculated aortic atheroma; or leftward aortic angel greater than or equal to 20 degrees with regard to vertical.
* Renal dysfunction limiting follow-up contrast-enhanced CR (estimated glomerular filtration rate, eGFR less than 30mL/min/1.73m\^2 if not already on renal replacement therapy)
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03432494
Study Brief:
Protocol Section:
NCT03432494