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:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT03752866
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
2. Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
Exclusion Criteria:
1. Have sepsis, including active endocarditis
2. Have any evidence of left ventricular or atrial thrombus
3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
4. Have a non-calcified aortic annulus
5. Have congenital bicuspid or unicuspid leaflet configuration
6. Are unable to tolerate antiplatelet/anticoagulant therapy
7. Are pregnant at the time of signing informed consent
8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03752866
Study Brief:
Protocol Section:
NCT03752866