Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Sep 24, 2024

Keywords

ClinConnect Summary

The DESTINATION Study is looking into whether patients with atrial fibrillation (AF) need to continue taking blood-thinning medications, called anticoagulants, after a successful procedure called catheter ablation. This procedure aims to restore a normal heartbeat by targeting the areas of the heart causing AF. Current guidelines suggest that patients should keep using anticoagulants to reduce stroke risk, but this may lead to unnecessary bleeding problems. The study will involve 3,160 patients who have had successful ablation and have not experienced a return of AF for at least 6 months. Researchers will compare the risks of blood clots and bleeding for those who stop anticoagulants versus those who continue, using smart wearable devices to monitor their heart rhythm over two years.

To be eligible for the trial, participants should be at least 18 years old and have been diagnosed with certain types of AF, such as paroxysmal (intermittent) or persistent AF. They must also have had successful ablation without complications and meet specific stroke risk criteria. During the study, participants will be followed closely for two years, and their experiences may help change how doctors care for AF patients in the future. It's important to note that the study is not yet recruiting participants, and there are strict criteria for who can join to ensure everyone's safety.

Gender

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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