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Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
Sponsor: China National Center for Cardiovascular Diseases
Summary
The DESTINATION Study investigates whether anticoagulation therapy is necessary after successful catheter ablation (CA) for atrial fibrillation (AF). Current guidelines recommend continued anticoagulation based on stroke risk scores, even post-ablation, potentially exposing patients to unnecessary bleeding risks. This international, multicenter, randomized controlled trial aims to compare thromboembolic and bleeding event risks between patients who continue and discontinue anticoagulation after ablation. The study involves 3,160 AF patients, all free of AF recurrence within 6 months to 1 year after ablation. Smart wearable monitors will track recurrence, and patients are followed for 24 months to assess event rates. Findings may reshape anticoagulation guidelines, improving clinical practice for AF patients worldwide.
Official title: Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation: DESTINATION Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3160
Start Date
2025-01
Completion Date
2029-12
Last Updated
2024-09-26
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (12)
Brigham and Women Hospital
Boston, Massachusetts, United States
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute)
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Yunnan Fuwai Cardiovascular Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China