Anticoagulation After RFCA

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Drug: Oral anticoagulant

• Registration Number: NCT03573037
• Lead Sponsor: Yong Seog Oh

Brief Summary

The anticoagulation therapy is needed when rhythm control strategy is applied in atrial fibrillation patients but adverse events such as major bleeding exist. This study aims to examine the prognostic inpact of the duration of anticoagulation after radiofrequency ablation of paroxismal atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score undergoing radiofrequency ablation is randomized into one month anticoagulation group and two months anticoagulation group after the procedure. Thromboembolic event and adverse event including major or minor bleeding would be compared.

Detailed Description

Catheter based radiofrequency ablation has been used in more than a decade as a rhythm control therapy. Recently, superior outcome to medical therapy has been constantly reported and the radiofrequency catheter ablation (RFCA) became popular globally. It is recommended to anticoagulate patients who received RFCA for atrial fibrillation at least two months after the procedure. However, a few reports suggest anticoagulation in selective patients according to CHADS2-Vasc score. Anticoagulants prevent thromboembolic event in atrial fibrillation but the risk of bleeding is increased in company. There is controversy in the duration of anticoagulation after RFCA of atrial fibrillation. The investigators aimed to investigate the association with thromboembolic and bleeding event of anticoagulation duration after RFCA of atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score who are undergoing RFCA are included and randomized by 1:1 ratio to one month anticoagulation group and two months anticoagulation group after RFCA. Any patient with an evidence of intracardiac thrombus is excluded. The primary endpoint is thromboembolic event in 6 months after RFCA and the secondary endpoint is bleeding event in 6 months after RFCA.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27
• Primary Completion: 2020-06
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• Under 75 years old Patients undergoing RFCA for paroxismal atrial fibrillation CHADS-Vasc score 0-1

Exclusion Criteria

• Presence of intracardiac thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-month anticoagulation group	Oral anticoagulant	Anticoagulation using warfarin or non-VKA oral anticoagulant for 1 month after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation.
2-month anticoagulation group	Oral anticoagulant	Anticoagulation using warfarin or non-VKA oral anticoagulant for 2 months after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation

Primary Outcome Measures

Name	Time	Method
Thromboembolic event	6 months	Composite of ischemic stroke, transient ischemic attack, or other systemic embolic events

Secondary Outcome Measures

Name	Time	Method
Major bleeding	6 months	bleeding events that result in a reduction in hemoglobin level of at least 20 g per liter, transfusion of at least 2 units of blood, or symptomatic bleeding in a critical area or organ

Trial Locations

Locations (1)

Seoul St Mary's Hospital; 🇰🇷 Seoul, Seo Ch-gu, Korea, Republic of