Anticoagulation After RFCA
Reducible
Duration of Anticoagulation Therapy Following Catheter Ablation of Atrial Fibrillation; Randomized Controlled Trial
1 other identifier
interventional
246
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jul 2014
Longer than P75 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJuly 27, 2018
July 1, 2018
5.9 years
April 24, 2017
July 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Thromboembolic event
Composite of ischemic stroke, transient ischemic attack, or other systemic embolic events
6 months
Secondary Outcomes (1)
Major bleeding
6 months
Study Arms (2)
1-month anticoagulation group
EXPERIMENTALAnticoagulation 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
ACTIVE COMPARATORAnticoagulation using warfarin or non-VKA oral anticoagulant for 2 months after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation
Interventions
1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation
Eligibility Criteria
You may qualify if:
- Under 75 years old Patients undergoing RFCA for paroxismal atrial fibrillation CHADS-Vasc score 0-1
You may not qualify if:
- Presence of intracardiac thrombus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yong Seog Ohlead
Study Sites (1)
Seoul St Mary's Hospital
Seoul, Seo Ch-gu, 137-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong-Seog Oh, MD,PhD
The Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 24, 2017
First Posted
June 29, 2018
Study Start
July 1, 2014
Primary Completion
June 1, 2020
Study Completion
August 1, 2020
Last Updated
July 27, 2018
Record last verified: 2018-07