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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03573037
Study type Interventional
Source Seoul St. Mary's Hospital
Contact Yong-Seog Oh, MD,PhD
Phone 82-2-2258-6035
Email oys@catholic.ac.kr
Status Recruiting
Phase N/A
Start date July 2014
Completion date August 2020

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