Anticoagulation After RFCA

NCT ID: NCT03573037

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2020-08-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1-month anticoagulation group

Anticoagulation using warfarin or non-VKA oral anticoagulant for 1 month after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation.

Group Type: EXPERIMENTAL

Oral anticoagulant

Intervention Type: DRUG

1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation

2-month anticoagulation group

Anticoagulation using warfarin or non-VKA oral anticoagulant for 2 months after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation

Group Type: ACTIVE_COMPARATOR

Oral anticoagulant

Intervention Type: DRUG

1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation

Interventions

Oral anticoagulant

1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Presence of intracardiac thrombus

• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yong Seog Oh

OTHER

Sponsor Role: lead

Responsible Party

Yong Seog Oh

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong-Seog Oh, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yong-Seog Oh, MD,PhD

Role: CONTACT

oys@catholic.ac.kr

82-2-2258-6035

Ju Youn Kim, MD

Role: CONTACT

zzoo921@catholic.ac.kr

82-10-5482-7307

Facility Contacts

Ju Youn Kim, MD

Role: primary

zzoo921@catholic.ac.kr

82-10-5482-7307

Other Identifiers

REDUCIBLE

Identifier Type: -

Identifier Source: org_study_id