NCT06615596 Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
| NCT ID | NCT06615596 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,160 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 3,160 participants in total. It began in 2025-08-05 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06615596 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06615596 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06615596 currently recruiting?
Yes, NCT06615596 is actively recruiting participants. Contact the research team at ianyao@263.net.cn for enrollment information.
Where is the NCT06615596 trial being conducted?
This trial is being conducted at Boston, United States, Beijing, China, Beijing, China, Guangzhou, China and 8 additional locations.
Who is sponsoring the NCT06615596 clinical trial?
NCT06615596 is sponsored by China National Center for Cardiovascular Diseases. The trial plans to enroll 3,160 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.