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

Korábbi kezelés

• The patient has previously implanted cardiac implantable electronic devices or ILR.

Más betegség

• 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 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.
• 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.
• The patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease).
• Known or suspected malignancy with a history of chemotherapy within 1 year.
• Patients with a history of left atrial appendage occlusion or left atrial appendage closure.

Laborértékek

• 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)

Életkor

• 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.

Egyéb

• Patients who are contraindicated to anticoagulants other than those listed above.
• Hypertrophic cardiomyopathy
• Patients who are taking warfarin or coumadin.
• Patients who are taking dual antiplatelet agents.
• The patient is participating in another randomized clinical trial and is under follow-up observation.

• Patients who are scheduled to undergo atrial fibrillation catheter ablation due to atrial fibrillation refractory to antiarrhythmic drug treatment.
• Patients with non-gender CHA2DS2-VASc score 1-4.
• Patients who are taking direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, edoxaban) and further plan taking them life-long to prevent stroke caused by atrial fibrillation.
• Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form.