Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
Recruiting now · Early Phase 1
Conditions studied: Atrial Fibrillation (AF)
In brief
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.
Key facts
- Study ID
- NCT06615596
- Run by
- China National Center for Cardiovascular Diseases
- People needed
- 3160
- Starts
- 2025-08-05
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Diagnosed paroxysmal, persistent, or longstanding persistent AF
- Successful procedure (defined as restoration of sinus rhythm after PV isolation for paroxysmal AF, restoration of sinus rhythm after PV isolation and completion of additional ablation for persistent AF, according to 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation) and no recurrence within 3 months of ablation, using a cooled tip RF-, laser- or cryo-balloon-catheter
- No periprocedural complications
- Signed informed consent
- Male with CHA2DS2-VASC score ≥1, female with score ≥2.
You may not qualify if…
- Valvular AF (moderate- severe mitral insufficiency; relevant mitral stenosis with a mean pressure gradient \>5mmHg)
- Reversible AF (e.g. uncontrolled hyperthyroidism)
- Prior AF ablation (including surgical ablation)
- History of left atrial appendage occlusion/ligation/excision
- Concomitant surgical ablation
- Left atrial diameter \>50 mm
- Left atrial or LAA thrombus
- Pregnancy/breast feeding
- Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
- Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation (i.e. PE, ventricular thrombus, peripheral thrombosis, etc)
- Recent myocardial infarction, NYHA class IV heart failure, patent foramen ovale, recent trauma or other prothrombotic conditions
- Patient with special risk factors for stroke unrelated to AF, specifically known thrombophilia/ hypercoagulability, uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease.
- Patient has bleeding contra-indication to oral anticoagulation (such as bleeding diathesis, hemorrhagic disorder, significant gastrointestinal bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding history, fibrinolysis within 48 hours of enrollment).
- Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent
- Patient has been on strong CYP3A inducers (such as rifampicin, phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors (such as ketoconazole or protease inhibitors) within 4 days of enrolment
- Structural congenital heart disease
- Recent stroke or intracranial hemorrhage within 6 months
- Inability to adequately understand nature, significance, implications and risks of study precipitation and to comply with follow-up (i.e. bipolar disorders, severe depression, suicidal tendencies, among others) as judged by the local physician, ongoing drug or alcohol addiction (\> 8 drinks/week)
- Patients who are \> 85 years of age
- Patients who are critically ill or who have a life expectancy \<3 years
- Patient is unable or unwilling to provide informed consent
- Patient is included in another randomized clinical trial or a clinical trial requiring an insurance
Where it is running
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
- Fuwai Hospital — Beijing, Beijing Municipality, China (enrolling)
- Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen, Guangdong, China (enrolling)
- Wuhan Asia Heart Hospital — Wuhan, Hubei, China (enrolling)
- Yunnan Fuwai Cardiovascular Hospital — Kunming, Yunnan, China
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China
- Brigham and Women Hospital — Boston, Massachusetts, United States
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China
- Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute) — Taiyuan, Shanxi, China
- Beijing Anzhen Hospital — Beijing, Beijing Municipality, China
- West China Hospital, Sichuan University — Chengdu, Sichuan, China
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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