Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

November 21, 2013 updated by: Young-Hoon Kim, Korea University Anam Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 136-705
        • Recruiting
        • Korea University Anam Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short term warfarin group
taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation
Drug: warfarin
Active Comparator: Conventional therapy arm
conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF
Drug: warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of thromboembolic and bleeding events during 2 months
Time Frame: 2 months after the procedure
2 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUMCEP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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