3,160
Participants
Start Date
January 31, 2025
Primary Completion Date
January 31, 2029
Study Completion Date
December 31, 2029
discontinue anticoagulation therapy
Participants in the discontinuation arm will cease anticoagulation therapy following randomization. Smart wearable devices will monitor for AF recurrence, and patients will be followed for 24 months, with primary endpoints including thromboembolic and bleeding events.
Anticoagulant drugs
Participants in the continuation arm will receive oral anticoagulant drugs such as dabigatran, rivaroxaban, apixaban, warfarin, etc. tailored to their specific risk profiles. The discontinuation arm will cease anticoagulation therapy following randomization. Smart wearable devices will monitor for AF recurrence, and patients will be followed for 24 months, with primary endpoints including thromboembolic and bleeding events.
Catheter Ablation
Catheter ablation is a medical procedure used to treat atrial fibrillation (AF) by targeting and destroying small areas of heart tissue that cause irregular heartbeats. Using a specialized catheter, radiofrequency energy, cryotherapy, or pulsed field ablation (PFA) is applied to isolate the pulmonary veins or ablate other specific heart areas. The goal is to restore normal heart rhythm by electrically isolating problematic areas responsible for AF. This FDA-regulated procedure is minimally invasive and requires follow-up monitoring for AF recurrence and other potential complications. No specific ablation technique is mandated, allowing flexibility for operators to choose based on their expertise and center practices. The ablation strategy may include pulmonary vein isolation or additional procedures based on the type of AF. This approach distinguishes the study by providing real-world applicability, reflecting the diversity of ablation methods used in clinical practice.
Beijing Anzhen Hospital, Beijing
Fuwai Hospital, Beijing
Brigham and Women Hospital, Boston
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, Shenzhen
Fuwai Central China Cardiovascular Hospital, Zhengzhou
Wuhan Asia Heart Hospital, Wuhan
Shanghai Chest Hospital, Shanghai
Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute), Taiyuan
West China Hospital, Sichuan University, Chengdu
Yunnan Fuwai Cardiovascular Hospital, Kunming
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou
China National Center for Cardiovascular Diseases
OTHER_GOV