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

Primary Purpose

Persistent Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
radiofrequency catheter ablation
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Focal ablation

Linear ablation

Arm Description

PV isolation + CFAE-targeted focal ablation

PV isolation + CFAE-guided linear ablation

Outcomes

Primary Outcome Measures

freedom from AF/AT more than 3 months after first ablation

Secondary Outcome Measures

freedom from AF/AT within 3 months following first ablation
acute intra-procedure termination of AF
organization of AF/conversion to AT during the ablation
procedure time
ablation time
procedure-related complication

Full Information

First Posted
March 1, 2010
Last Updated
March 19, 2018
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01088126
Brief Title
Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation
Official Title
Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Withdrawn
Why Stopped
It was difficult to enrol patients.
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
March 2, 2017 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea University Anam Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focal ablation
Arm Type
Active Comparator
Arm Description
PV isolation + CFAE-targeted focal ablation
Arm Title
Linear ablation
Arm Type
Active Comparator
Arm Description
PV isolation + CFAE-guided linear ablation
Intervention Type
Procedure
Intervention Name(s)
radiofrequency catheter ablation
Intervention Description
radiofrequency catheter ablation, NavX system
Primary Outcome Measure Information:
Title
freedom from AF/AT more than 3 months after first ablation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
freedom from AF/AT within 3 months following first ablation
Time Frame
3 months
Title
acute intra-procedure termination of AF
Time Frame
12 months
Title
organization of AF/conversion to AT during the ablation
Time Frame
12 months
Title
procedure time
Time Frame
12 months
Title
ablation time
Time Frame
12 months
Title
procedure-related complication
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoon Kim, M.D., Ph.D.
Organizational Affiliation
Korea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Medical Center
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

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

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