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Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01991951
Recruitment Status : Unknown
Verified November 2013 by Young-Hoon Kim, Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Young-Hoon Kim, Korea University Anam Hospital

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: warfarin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2017

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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



Primary Outcome Measures :
  1. Incidence of thromboembolic and bleeding events during 2 months [ Time Frame: 2 months after the procedure ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991951


Contacts
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Contact: Jaemin Shim, MD 82-10-6776-1195 jshim@kumc.or.kr

Locations
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Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Jaemin Shim, MD    82-10-6776-1195    jshim@kumc.or.kr   
Sponsors and Collaborators
Korea University Anam Hospital

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Responsible Party: Young-Hoon Kim, Professor of medicine, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01991951     History of Changes
Other Study ID Numbers: KUMCEP01
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants