Discontinuing blood thinners after successful catheter ablation for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicenter randomized trial enrolls 3,160 adults with atrial fibrillation who had a successful ablation and no AF recurrence for 6 to 12 months. Participants are randomized to either continue or discontinue anticoagulant therapy and are monitored with smart wearables every three months for 24 months to detect ischemic strokes, systemic embolism, major bleeding, and AF recurrence. The primary endpoint is a composite of ischemic stroke, systemic embolism, and major bleeding over two years; secondary endpoints include AF recurrence, need for re-ablation, and quality of life. Wearable data and clinic visits occur at scheduled intervals to ensure comprehensive capture of events. If results are favorable, findings could influence international guidelines on post-ablation anticoagulation, potentially reducing unnecessary bleeding risk with no increase in thromboembolism.

Why it matters

Who can join: the full rules

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

Where it's running

• Fuwai Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
  Shenzhen, Guangdong, China Recruiting
• Wuhan Asia Heart Hospital
  Wuhan, Hubei, China Recruiting
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Brigham and Women Hospital
  Boston, Massachusetts, United States Not yet recruiting
• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yan Yao, PhD
• Email: ianyao@263.net.cn
• Phone: 13901121319

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.