Linear Ablation Versus Focal Ablation of Complex Fraction... | NCT01088126

Studies
Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation

NCT01088126

Sponsor

Korea University Anam Hospital

Status

Withdrawn

Last Update Posted

Mar 20, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Persistent Atrial Fibrillation

Interventions

radiofrequency catheter ablation

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

Jan 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It was difficult to enrol patients.

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Mar 2, 2017Actual

First Submitted Date

Mar 1, 2010

First Submission Date that Met QC Criteria

Mar 16, 2010

First Posted Date

Mar 17, 2010Estimated

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

Mar 19, 2018

Last Update Posted Date

Mar 20, 2018Actual

Description Module

Brief Summary

The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Focal ablation	Active Comparator	PV isolation + CFAE-targeted focal ablation	Procedure: radiofrequency catheter ablation
Linear ablation	Active Comparator	PV isolation + CFAE-guided linear ablation	Procedure: radiofrequency catheter ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiofrequency catheter ablation	Procedure	radiofrequency catheter ablation, NavX system	Focal ablation Linear ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
freedom from AF/AT more than 3 months after first ablation		12 months

Secondary Outcomes

Measure	Description	Time Frame
freedom from AF/AT within 3 months following first ablation		3 months
acute intra-procedure termination of AF		12 months
organization of AF/conversion to AT during the ablation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients age 18 or greater
persistent atrial fibrillation
candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication
at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial
continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation
patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

paroxysmal or permanent atrial fibrillation
patients with AF felt to be secondary to an obvious reversible cause
inadequate anticoagulation as defined in the inclusion criteria
left atrial thrombus on TEE prior to procedure
contraindications to systemic anticoagulation with heparin or coumadin
previously undergone atrial fibrillation ablation
patients who are or may potentially be pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young-Hoon Kim, M.D., Ph.D.	Korea University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Medical Center		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
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided