Cardiac Ablation Clinical Trials

Clinical trials related to Cardiac Ablation Procedure

Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation: DESTINATION Study

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Behavioral, Procedure
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women Hospital
NOT_YET_RECRUITING
Boston
Other Locations
China
Beijing Anzhen Hospital
NOT_YET_RECRUITING
Beijing
Fuwai Hospital
RECRUITING
Beijing
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Yunnan Fuwai Cardiovascular Hospital
NOT_YET_RECRUITING
Kunming
Shanghai Chest Hospital
NOT_YET_RECRUITING
Shanghai
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
RECRUITING
Shenzhen
Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute)
NOT_YET_RECRUITING
Taiyuan
Wuhan Asia Heart Hospital
RECRUITING
Wuhan
Fuwai Central China Cardiovascular Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Yan Yao, PhD
ianyao@263.net.cn
13901121319
Backup
Lingmin Wu, Phd
wulingmin@fuwai.com
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 3160
Treatments
Active_comparator: on-OAC
In the cohort assigned to the on-OAC arm, which entails the continuation of Oral Anticoagulant (OAC) therapy, patients were prescribed Non-Vitamin K Antagonist Oral Anticoagulants (NOACs), specifically dabigatran, rivaroxaban, or apixaban, for a duration of 24 months following randomization. The dosing regimen was as follows: (1) Standard dosage included rivaroxaban at 20mg daily, apixaban at 5mg twice daily, and dabigatran at 150mg twice daily. (2) Reduced dosage was administered in cases where patients were aged over 75 years, had a body weight less than 50kg, or exhibited creatinine clearance below 50ml/min.
Experimental: off-OAC
In the off-OAC, involving the discontinuation of OAC therapy, patients had their OAC treatment terminated post-randomization, and no placebo medication was administered as a substitute.
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov

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