Search / Trial NCT06615596

Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation

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

Trial Information

Current as of October 09, 2024

Not yet recruiting

Keywords

Atrial Fibrillation Catheter Ablation Anticoagulation Discontinuation Post Ablation Monitoring Randomized Controlled Trial Thromboembolic Risk Smart Wearable Devices Af Recurrence Detection

Description

This prospective, international, multicenter randomized controlled trial (RCT) investigates the safety and necessity of continuing anticoagulation therapy after successful catheter ablation of atrial fibrillation. The study will enroll 3,160 patients who underwent catheter ablation for AF and achieved no recurrence within 6 months to 1 year post-procedure. Participants will be randomly assigned to either continue or discontinue anticoagulation therapy. Smart wearable devices will monitor AF recurrence every 3 months, detecting both symptomatic and asymptomatic events. The study\'s prima...

Gender

ALL

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

About China National Center For Cardiovascular Diseases

The China National Center for Cardiovascular Diseases (NCCD) is a leading research and clinical trial sponsor dedicated to advancing cardiovascular health in China and globally. As a prominent institution, NCCD focuses on innovative research, clinical management, and education in cardiovascular medicine. The center plays a crucial role in conducting rigorous clinical trials aimed at developing new therapies and improving patient outcomes for cardiovascular diseases. Through collaboration with national and international partners, NCCD is committed to enhancing the understanding of cardiovascular conditions and translating research findings into practical applications for improved healthcare.

Locations

Beijing, Beijing, China

Chengdu, Sichuan, China

Wuhan, Hubei, China

Guangzhou, Guangdong, China

Shanghai, Shanghai, China

Hangzhou, Zhejiang, China

Zhengzhou, Henan, China

Boston, Massachusetts, United States

Shenzhen, Guangdong, China

Beijing, Beijing, China

Taiyuan, Shanxi, China

Kunming, Yunnan, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0