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 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT05171712
Eligibility Criteria:
Inclusion Criteria:
1. Subject must provide written informed consent prior to any clinical investigation-related procedure.
2. Are \>60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant.
3. Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
Exclusion Criteria:
1. Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.)
2. Have sepsis, including active endocarditis
3. Have any evidence of left ventricular or atrial thrombus
4. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
5. Have a non-calcified aortic annulus
6. Have congenital bicuspid or unicuspid leaflet configuration
7. Are unable to tolerate antiplatelet/anticoagulant therapy
8. Are pregnant at the time of signing informed consent
9. Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05171712
Study Brief:
Protocol Section:
NCT05171712