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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07434661
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years at the time of enrolment
* Open heart aortic or mitral valve repair or biological valve replacement in the last 10 days
* Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation),
* Informed consent from either the patient or a substitute decision-maker.
Exclusion Criteria:
* Mechanical valve replacement
* Antiphospholipid syndrome (triple positive)
* Severe renal failure (Cockcroft-Gault equation; creatinine clearance \<15 ml/min)
* Known significant liver disease (Child-Pugh classification B and C)
* Left ventricular thrombus
* Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis
* Known contraindication for any DOAC or VKA
* Women who are pregnant, breastfeeding, or of childbearing potential
* Follow-up not possible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07434661
Study Brief:
Protocol Section:
NCT07434661