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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT02039167
Eligibility Criteria:
Inclusion Criteria:
* Paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF), documented by electrocardiography performed at screening or within the prior 6 months
* Indication for oral anticoagulation as assessed by CHA2DS2-VASc-Score (≥ 2)
* Severe to end-stage chronic kidney disease (eGFR \< 30 ml/min as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
* 18 to 80 years, inclusive
* Life expectancy of at least 2 years
* Negative pregnancy test for women
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
* Written informed consent
Exclusion Criteria:
* AF due to a reversible cause or a singular occurrence of AF
* Conditions other than AF that require anticoagulation
* Transient ischemic attack or stroke within previous 3 months
* A need for Aspirin (at a dose of \> 162.5 mg/day) or for both Aspirin and Clopidogrel/other antiplatelet drugs (daily administration) other than for clinical investigation
* Contraindications or allergies to vitamin K antagonists, Aspirin or Clopidogrel
* Previous closure (surgical, interventional) of the left atrial appendage (LAA)
* Previous closure of atrial septal defect (ASD) / persistent foramen ovale (PFO)
* Active internal bleeding
* Thrombocytopenia (\< 100,000 platelets/mm3)
* History of or planned organ transplantation
* Planned Mitra Clip or transcatheter aortic valve implantation (TAVI) intervention
* Planned cardiac surgery
* History of intracranial, intraocular or retroperitoneal bleeding
* Severe GI-bleeding within the last 3 months
* Hemorrhagic gastro-intestinal diseases (e.g., ulcerative colitis)
* History of or condition associated with increased bleeding risk
* Uncontrolled arterial hypertension
* Heparin-induced thrombocytopenia type II
* Known inherited coagulation disorders
* Severe liver dysfunction (spontaneous INR \> 1.5) or liver cirrhosis ≥ CHILD B
* Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
* Women who are planning to become pregnant, or who are breastfeeding
* Active infection of any kind
Transesophageal echocardiography (TEE) Exclusion Criteria
* Intracardiac thrombus or dense spontaneous echo contrast as visualized by TEE (with use of sonovue in suspicious cases)
* Significant mitral valve stenosis
* Any congenital heart disease, including atrial septal defect
* Pericardial effusion during ECHO assessment of \> 2 mm
* Cardiac tumor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02039167
Study Brief:
Protocol Section:
NCT02039167