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Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
warfarin
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation
  • Patients with CHADS-VASc score 2 or less than 2

Exclusion Criteria:

  • Patients who do not consent to the study
  • Permanent or persistent atrial fibrillation
  • Patients who have underwent prior catheter ablation for atrial fibrillation
  • CHADS-VASc score more than 2
  • History of stroke
  • LVEF <40%
  • Significant liver or kidney dysfunction
  • History of major bleeding during warfarin therapy

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short term warfarin group

Conventional therapy arm

Arm Description

taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation

conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF

Outcomes

Primary Outcome Measures

Incidence of thromboembolic and bleeding events during 2 months

Secondary Outcome Measures

Full Information

First Posted
November 18, 2013
Last Updated
November 21, 2013
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01991951
Brief Title
Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation
Official Title
Prospective Randomized Study of Incidence of Thromboembolic and Bleeding Events According to the Period of Warfarin Use Before and After Catheter Ablation of Paroxysmal Atrial Fibrillation in Low Risk Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

5. Study Description

Brief Summary
We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short term warfarin group
Arm Type
Experimental
Arm Description
taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation
Arm Title
Conventional therapy arm
Arm Type
Active Comparator
Arm Description
conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF
Intervention Type
Drug
Intervention Name(s)
warfarin
Primary Outcome Measure Information:
Title
Incidence of thromboembolic and bleeding events during 2 months
Time Frame
2 months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation Patients with CHADS-VASc score 2 or less than 2 Exclusion Criteria: Patients who do not consent to the study Permanent or persistent atrial fibrillation Patients who have underwent prior catheter ablation for atrial fibrillation CHADS-VASc score more than 2 History of stroke LVEF <40% Significant liver or kidney dysfunction History of major bleeding during warfarin therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaemin Shim, MD
Phone
82-10-6776-1195
Email
jshim@kumc.or.kr
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaemin Shim, MD
Phone
82-10-6776-1195
Email
jshim@kumc.or.kr

12. IPD Sharing Statement

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Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

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