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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04045093
Eligibility Criteria:
Inclusion Criteria:
* Patients with atrial fibrillation documented with standard 12-lead ECG documented atrial fibrillation on the day of screening or randomization
* Patients with age ≥ 18 years
* Patients with moderate or severe mitral stenosis, i.e. mitral valvular area (MVA) ≤ 2.5cm2
* Patients should be able to provide a written informed consent
* Patients should have all 4 inclusion-criteria fulfilled to be qualified for the study
Exclusion Criteria:
* Patients with mechanical prosthetic valve, or with active endocarditis
* Patients with planned valvular intervention within 1 year
* Patients with left atrial appendage occlusive device
* Patients with planned AF ablation
* Unexplained anemia (haemoglobin level \< 10g/dL) or thrombocytopenia (platelet count \< 100x10\*9/L)
* Need for anticoagulant therapy of disorders other than atrial fibrillation
* Patients receiving antiplatelet therapy for disorders other than atrial fibrillation
* Uncontrolled hypertension (systolic blood pressure \> 180mmHg and/or diastolic blood pressure \> 100mmHg)
* Estimated creatinine clearance ≤ 30mL/min
* Liver dysfunction of Child Pugh stage B or C
* Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
* Patients considered unreliable by the investigator or have a life expectancy less than 1 year because of concomitant disease, or has any condition, which in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04045093
Study Brief:
Protocol Section:
NCT04045093