Short Term Warfarin Therapy for Radiofrequency Catheter A... | NCT01991951

Studies
Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

NCT01991951

Sponsor

Korea University Anam Hospital

Status

Unknown status

Last Update Posted

Nov 25, 2013Estimated

Enrollment

520Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

warfarin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Nov 18, 2013

First Submission Date that Met QC Criteria

Nov 21, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Young-Hoon Kim, Professor of medicine, Korea University Anam HospitalPrincipal Investigator

Lead Sponsor

Korea University Anam HospitalOTHER

Collaborators

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

520Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Short term warfarin group	Experimental	taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation	Drug: warfarin
Conventional therapy arm	Active Comparator	conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF	Drug: warfarin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
warfarin	Drug		Conventional therapy arm Short term warfarin group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jaemin Shim, MD	Contact	82-10-6776-1195		jshim@kumc.or.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Anam Hospital	Recruiting	Seoul		136-705	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014859	Warfarin

Ancestor Terms

ID	Term
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573

Browse Leaves

Not provided

Browse Branches

Not provided