Atrial fibrillation
Conditions
Interventions
"on-OAC" arm:Oral anticoagulant
"off-OAC" arm:Discontinue anticoagulants
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Patients who have reached the successful intraoperative ablation endpoint of atrial fibrillation radiofrequency ablation surgery and have no recurrence 3 months after surgery (according to the expert consensus of atrial fibrillation ablation catheters, the successful endpoint of intraoperative ablation for paroxysmal atrial fibrillation is sinus rhythm and complete electrical isolation of pulmonary venous potential at the end of ablation, and the successful endpoint of intraoperative ablation for persistent atrial fibrillation and long-term persistent atrial fibrillation is sinus rhythm and complete electrical isolation of pulmonary venous potential at the end of ablation, and supplementary ablation reaches the ablation endpoint); (2) no perioperative complications; (3) Signed informed consent for the study; (4) CHA2DS2-VASC score >=1 for males and CHA2DS2>=2 for females.
Exclusion criteria
Exclusion criteria: (1) Valvular pathic atrial fibrillation (moderate and above mitral stenosis); (2) Previous history of atrial fibrillation ablation (including medical and surgical ablation); (3) History of left atrial appendage closure or left atrial appendage resection/ligation surgery or planned to undergo such surgery; (4) The anterior and posterior diameter of the left atrium >50mm; (5) Atrial fibrillation secondary to treatable diseases (such as uncontrolled hyperthyroidism, etc.); (6) pregnancy; (7) Patients who cannot stop anticoagulation therapy due to comorbidities, such as left atrial thrombosis or left atrial appendage thrombosis, pulmonary embolism, ventricular thrombosis, peripheral thrombosis, cardiac mechanical valve replacement, etc. (8) Have specific risk factors for stroke unrelated to atrial fibrillation, including known thrombotic disease/hypercoagulable state, uncontrolled hypertension (systolic blood pressure >180mmHg and/or diastolic blood pressure >100mmHg measured within 4 days prior to enrollment), untreated familial hyperlipidemia, known vascular abnormalities (intracranial aneurysm/arteriovenous malformation or chronic vascular dissection), or known severe carotid artery disease; (9) Have contraindications to oral anticoagulation (e.g., bleeding tendency, bleeding disorder, significant gastrointestinal bleeding within the past 6 months, history of intracranial/intraocular/non-traumatic bleeding, fibrinolytic therapy within 48 hours prior to enrollment, etc.); (10) Planned use or prior use of strong CYP3A inducers (such as rifampicin, phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors (such as ketoconazole or protease inhibitors) within 4 days prior to enrollment; (11) Patients with myocardial infarction (within 1 year), heart failure above NYHA cardiac function class IV., recent trauma and other embolic events; (12) Patients with a definite diagnosis of severe congenital heart disease; (13) Patients with new severe cerebral infarction in the past 3 months or cerebral infarction or transient ischemic attack within 14 days; (14) Patients who need to take antiplatelet aggregation drugs; (15) Patients who are unable to adequately understand the nature, significance, impact, and risks of study participation, or who are unable to cooperate with follow-up requirements (e.g., bipolar disorder, severe depression, suicidal tendencies, etc.); (16) Patients over 85 years of age or under 18 years of age; (17) Patients who are critically ill or have a life expectancy of less than 3 years; (18) do not agree to participate in this study; (19) Patient has participated in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ischemic stroke / systemic embolism;Bleeding event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of ischemic stroke;Systemic thromboembolism within the 1-year post-ablation period and the incidence of clinically significant bleeding; | — |
Countries
China
Contacts
Public ContactYan Yao
Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed