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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT03715894
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing transfemoral SAPIEN 3 implantation because of aortic stenosis,
* at least 1 of the identified risk factors from the retrospective part to ensure a minimum risk of 33% for PPI (presumed: pre-existing conduction disturbance, aortic valve calcification, heavily calcified LVOT, RBBB, persistent complete heart blocks, QRS duration or short membranous septum,to be confirmed);
Exclusion Criteria:
* exclusion of patients with prior pacemaker,
* with indications for pacemaker implantation prior to TAVI
* valve in valve implantation or
* without informed consent
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03715894
Study Brief:
Protocol Section:
NCT03715894