Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991951
• Other study ID #: KUMCEP01
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2013
• Last updated: November 21, 2013
• Start date: July 2013
• Est. completion date: July 2017

Study information

• Verified date: November 2013
• Source: Korea University Anam Hospital
• Contact: Jaemin Shim, MD
• Phone: 82-10-6776-1195
• Email: jshim[@]kumc.or.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: July 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• warfarin

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of thromboembolic and bleeding events during 2 months		2 months after the procedure	Yes