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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT03001960
Eligibility Criteria:
Inclusion criteria:
* Patients \>18 years and \<90 years
* Patients undergoing TF-TAVI for severe aortic stenosis (combined with aortic regurgitation)
* Informed consent
Exclusion criteria:
* TIA/Stroke within last 90 days
* Aortic valve-in-valve procedures
* TAVI for treatment of isolated aortic regurgitation
* known significant carotid stenosis (\>70%)
* Prior myocardial infarction or revascularization with PCI or CABG within past 3 months
* Clopidogrel and/ or Aspirin within past 7 days
* any other indication for (dual) antiplatelet therapy
* Contraindication to MRI (MRI conditional pacemakers accepted!)
* participation in another interventional trial
* cardiogenic shock (positive shock index OR need for catecholamine support OR systolic bloodpressure \< 90 mmHg) or need for pre-hospital intubation
* cardiac arrest \<90 days prior to randomization
* Pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03001960
Study Brief:
Protocol Section:
NCT03001960