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Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

NCT ID: NCT01991951

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short term warfarin group

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

Group Type EXPERIMENTAL

warfarin

Intervention Type DRUG

Conventional therapy arm

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

Group Type ACTIVE_COMPARATOR

warfarin

Intervention Type DRUG

Interventions

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warfarin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young-Hoon Kim

Professor of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jaemin Shim, MD

Role: CONTACT

Phone: 82-10-6776-1195

Email: [email protected]

Facility Contacts

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Jaemin Shim, MD

Role: primary

Other Identifiers

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KUMCEP01

Identifier Type: -

Identifier Source: org_study_id