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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02903420
Eligibility Criteria:
Inclusion Criteria:
* Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.
* Patient has senile degenerative aortic valve stenosis
* Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.
* Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.
Exclusion Criteria:
* Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
* Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.
* Patient has severe aortic valve regurgitation.
* Patient has severe mitral valve regurgitation.
* Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.
* Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02903420
Study Brief:
Protocol Section:
NCT02903420