Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation

Exclusion Criteria22

• Patients with a stroke/transient ischemic attack history.
• Patients with underlying diseases and bleeding findings contraindicated to anticoagulation (e.g., coagulation disorders, bleeding conditions, significant gastrointestinal bleeding within 6 months of enrollment, history of intracranial/intraocular/nontraumatic bleeding, thrombolysis within 48 hours of study enrollment).
• Patients who are contraindicated to anticoagulants other than those listed above.
• Patients who are hemodynamically unstable at the time of study enrollment: cardiogenic shock, treatment-unresponsive ventricular arrhythmia, or congestive heart failure (NYHA class IV) at the time of randomization.
• Patients with underlying severe anemia (hemoglobin \<8 g/dL at baseline) or a transfusion history within four weeks before visit 1.
• Patients with underlying severe thrombocytopenia (platelet count \<50,000/mm3)
• The patient is under dialysis or chronic renal failure (creatinine clearance \<15ml/min)
• The patient has severe liver disease (variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
• The patient has a contraindication to the implantation of an implantable loop recorder (ILR) (such as limited immunocompetence or a wound-healing disorder).
• The patient has severe valvular disease (valvular prosthesis, mitral valve repair; rheumatic mitral stenosis is excluded irrespective of the severity of the disease).
• The patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
• Hypertrophic cardiomyopathy
• The patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease).
• Patients who are taking warfarin or coumadin.
• Patients who are taking dual antiplatelet agents.
• Patients with a history of Cox-Maze surgery or atrial fibrillation catheter ablation for atrial fibrillation treatment.
• Pregnancy, breastfeeding, or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study. \*
• \* Medically acceptable contraceptives include condoms, injectable or implantable contraceptives, intrauterine devices, and oral contraceptives.
• Known or suspected malignancy with a history of chemotherapy within 1 year.
• The patient has previously implanted cardiac implantable electronic devices or ILR.
• Patients with a history of left atrial appendage occlusion or left atrial appendage closure.
• The patient is participating in another randomized clinical trial and is under follow-up observation.