Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

3,160

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

January 31, 2029

Study Completion Date

December 31, 2029

Conditions
Atrial Fibrillation (AF)
Interventions
BEHAVIORAL

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.

DRUG

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.

PROCEDURE

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.

Trial Locations (12)

100011

Beijing Anzhen Hospital, Beijing

100037

Fuwai Hospital, Beijing

02115

Brigham and Women Hospital, Boston

Unknown

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

All Listed Sponsors
lead

China National Center for Cardiovascular Diseases

OTHER_GOV