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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT02556203
Eligibility Criteria:
Inclusion Criteria:
* Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis (either native or valve-in-valve)
* By iliofemoral or subclavian access
* With any approved/marketed device
Exclusion Criteria:
* Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment
* Any other indication for continued treatment with any oral anticoagulant (OAC)
* Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level \< 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)
* Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of screening that is unrelated to the TAVR procedure
* Clinically overt stroke within the last 3 months
* Planned coronary or vascular intervention or major surgery
* Severe renal impairment (eGFR \< 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
* Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02556203
Study Brief:
Protocol Section:
NCT02556203