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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02486367
Eligibility Criteria:
Inclusion Criteria:
1. Valvular heart disease and a clinical indication for TAVR
2. Age of 18 years or older
3. Capable of informed consent
4. Planned transfemoral TAVR
Exclusion Criteria:
1. Prior history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage
2. Established bleeding diathesis or thrombocytopenia (\<150k/dl)
3. End-stage renal disease
4. Severe hepatic impairment or liver cirrhosis
5. Pregnancy
6. Current infection
7. History of autoimmune disease
8. Established allergy to contrast agents, thienopyridines, aspirin, or ticagrelor
9. History of solid organ transplantation
10. Atrial Fibrillation, DVT, PE or other indication for long term anti-coagulation
11. Plan for direct aortic access or trans-apical TAVR
12. Enrollment in another clinical trial
13. Recent (\< 12 months) or active excessive bleeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02486367
Study Brief:
Protocol Section:
NCT02486367