Anticoagulation After RFCA (Reducible)

Duration of Anticoagulation Therapy Following Catheter Ablation of Atrial Fibrillation; Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Oral anticoagulant

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 Type: Interventional
• Enrollment (Anticipated): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seo Ch-gu
    • Seoul, Seo Ch-gu, Korea, Republic of, 137-701
      • Recruiting
      • Seoul St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 74 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Oral anticoagulant; 1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation
ACTIVE_COMPARATOR: 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	Drug: Oral anticoagulant; 1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic event	Composite of ischemic stroke, transient ischemic attack, or other systemic embolic events	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	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	6 months

Collaborators and Investigators

• Sponsor: Yong Seog Oh

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (ACTUAL): June 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anticoagulants
• Other Study ID Numbers: REDUCIBLE