Recruiting
Phase EARLY_PHASE1
Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
Condition(s) studied
Atrial Fibrillation (AF)
Investigational drug(s) / intervention(s)
discontinue anticoagulation therapyAnticoagulant drugsCatheter Ablation
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.
Study 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Primary outcome measure(s)
- Composite outcome consisting of thromboembolic events and clinically significant bleeding events — 24 month
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).
Trial sites (12)
| Facility | City | Region | Status |
|---|
| Brigham and Women Hospital |
Boston |
Massachusetts |
Not Yet Recruiting |
| Beijing Anzhen Hospital |
Beijing |
Beijing Municipality |
Not Yet Recruiting |
| Fuwai Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University |
Guangzhou |
Guangdong |
Not Yet Recruiting |
| Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen |
Shenzhen |
Guangdong |
Recruiting |
| Fuwai Central China Cardiovascular Hospital |
Zhengzhou |
Henan |
Not Yet Recruiting |
| Wuhan Asia Heart Hospital |
Wuhan |
Hubei |
Recruiting |
| Shanghai Chest Hospital |
Shanghai |
Shanghai Municipality |
Not Yet Recruiting |
| Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute) |
Taiyuan |
Shanxi |
Not Yet Recruiting |
| West China Hospital, Sichuan University |
Chengdu |
Sichuan |
Not Yet Recruiting |
| Yunnan Fuwai Cardiovascular Hospital |
Kunming |
Yunnan |
Not Yet Recruiting |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine |
Hangzhou |
Zhejiang |
Recruiting |
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