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.
This prospective, international, multicenter randomized controlled trial (RCT) investigates the safety and necessity of continuing anticoagulation therapy after successful catheter ablation of atrial fibrillation. The study will enroll 3,160 patients who underwent catheter ablation for AF and achieved no recurrence within 6 months to 1 year post-procedure. Participants will be randomly assigned to either continue or discontinue anticoagulation therapy. Smart wearable devices will monitor AF recurrence every 3 months, detecting both symptomatic and asymptomatic events. The study\'s primary endpoint is a composite of ischemic stroke, systemic embolism, and major bleeding at a 24-month follow-up. Secondary outcomes include AF recurrence rates, re-ablation needs, and quality of life measures. Participants are monitored through follow-up visits at 3, 6, 12, 18, and 24 months, and data from wearable devices will be transmitted to the research team. This study is significant due to the diversity of the population, with sites in China and the US, allowing for results that are generalizable across ethnic and geographic lines. The trial\'s findings aim to provide high-quality evidence to inform future guideline recommendations regarding post-ablation anticoagulation therapy, potentially reducing unnecessary bleeding risks and optimizing treatment outcomes. The inclusion of smart wearable monitors enhances the detection of asymptomatic recurrences and provides continuous, reliable data on patient health during the follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,160
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.
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 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.
Brigham and Women Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGBeijing Anzhen Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGFuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China
RECRUITINGFuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGWuhan Asia Heart Hospital
Wuhan, Hubei, China
RECRUITINGShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute)
Taiyuan, Shanxi, China
NOT_YET_RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITING...and 2 more locations
Composite outcome consisting of thromboembolic events and clinically significant bleeding events
The primary endpoint of this study comprises a composite outcome consisting of thromboembolic events and clinically significant bleeding events. Specifically, it encompasses the following components: 1. Incidence of ischemic stroke and systemic thromboembolism within the 2-year post-ablation period in each respective study group. 2. Incidence of clinically significant bleeding within the 2-year post-ablation period in each respective study group. Unit of Measure: Number of events (strokes, systemic embolism, major bleeding episodes).
Time frame: 24 month
AF Recurrence Rate
Percentage of patients with documented AF recurrence at 2 years.
Time frame: 24 month
Repeat Ablation Proportion
Percentage of patients undergoing repeat ablation within each group
Time frame: 24 month
Thromboembolic/Bleeding Event Rates after repeat procedure
Percentage of patients with Thromboembolic and Bleeding events after repeat ablation in each group
Time frame: 24 month
Thromboembolic/Bleeding Event Rates after recurrence in off-OAC
Percentage of patients with thromboembolic and bleeding event rates in patients resuming anticoagulation therapy due to AF recurrence in the no anticoagulation group
Time frame: 24 month
Major Adverse Cardiovascular Events (MACE)
Number of MACE events including acute coronary syndrome, acute myocardial infarction (MI), serious arrhythmias, heart failure, cardiovascular mortality, and all-cause mortality in each group
Time frame: 24 month
Complication rates
Incidence rates of complications include bleeding, cardiac tamponade, vascular damage, pulmonary vein stenosis, stroke or thromboembolism, heart block, esophageal injury, infection, etc. based on different ablation method
Time frame: 24 month
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