KCT0008995招募中Unknown
Comparison between continuous oral anticoagulation versus pill-in-the-POCKET Oral AntiCoagulation strategy guided by continuous rhythm monitoring using implantable loop recorder after atrial fibrillation catheter ablation
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 89(Year)（—）
- 性别
- All
入选标准
- •Subjects must meet all the following criteria:
- •1. Patients who are scheduled to undergo atrial fibrillation catheter ablation due to atrial fibrillation refractory to antiarrhythmic drug treatment.
- •2. Patients with non-gender CHA2DS2-VASc score 1-4.
- •3. Patients who are taking direct oral anticoagulants and further plan taking them life-long to prevent stroke caused by atrial fibrillation.
- •4. Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form.
排除标准
- •1. Patients with a stroke/transient ischemic attack (TIA) history.
- •2. 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).
- •3. Patients who are contraindicated to anticoagulants other than those listed above.
- •4. 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.
- •5. Patients with underlying severe anemia (hemoglobin <8 g/dL at baseline) or a transfusion history within four weeks before randomization.
- •6. Patients with underlying severe thrombocytopenia (platelet count <50,000/mm3)
- •7. Patients is under dialysis or chronic renal failure (creatinine clearance <15ml/min)
- •8. Patients has severe liver disease (variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
- •9. Patients has a contraindication to implantation of an ILR (such as limited immunocompetence or a wound-healing disorder).
- •10. Patient has severe valvular disease (valvular prosthesis, mitral valve repair; however, rheumatic valve disease, regardless of severity, is not eligible for enrollment.).
- •11. Patient has a non-arrhythmic condition necessitating long-term OAC.
- •12. Hypertrophic cardiomyopathy
- •13. Patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease).
- •14. Patients who are taking warfarin or coumadin.
- •15. Patients who are taking dual antiplatelet agents (DAPT).
- •16. Patients with a history of Cox-Maze surgery or atrial fibrillation catheter ablation for atrial fibrillation treatment.
- •17. Pregnancy or breastfeeding or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study. *
- •* Medically acceptable contraceptive includes condom, injectable or implantable contraceptives, intrauterine devices, and oral contraceptives.
- •18. Patients with a history of malignancy and chemotherapy within the last 1 year
- •19. Previously received an implantable cardiac electrical device or implantable loop recorder.
- •20. Previously received a left atrial appendage occlusion or left atrial appendage closure.
- •21. Patients who are participating in another randomized clinical trial and under follow-up observation.
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