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

This study has been withdrawn prior to enrollment.
(It was difficult to enrol patients.)
Information provided by:
Korea University Anam Hospital Identifier:
First received: March 1, 2010
Last updated: October 4, 2016
Last verified: January 2010
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.

Condition Intervention
Persistent Atrial Fibrillation
Procedure: radiofrequency catheter ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • freedom from AF/AT more than 3 months after first ablation [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • freedom from AF/AT within 3 months following first ablation [ Time Frame: 3 months ]
  • acute intra-procedure termination of AF [ Time Frame: 12 months ]
  • organization of AF/conversion to AT during the ablation [ Time Frame: 12 months ]
  • procedure time [ Time Frame: 12 months ]
  • ablation time [ Time Frame: 12 months ]
  • procedure-related complication [ Time Frame: 12 months ]

Enrollment: 0
Study Start Date: January 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Focal ablation
PV isolation + CFAE-targeted focal ablation
Procedure: radiofrequency catheter ablation
radiofrequency catheter ablation, NavX system
Active Comparator: Linear ablation
PV isolation + CFAE-guided linear ablation
Procedure: radiofrequency catheter ablation
radiofrequency catheter ablation, NavX system


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01088126

Korea, Republic of
Korea University Medical Center
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Principal Investigator: Young-Hoon Kim, M.D., Ph.D. Korea University
  More Information

Responsible Party: Young-Hoon Kim, Korea University Anam Hospital Identifier: NCT01088126     History of Changes
Other Study ID Numbers: AN09239
Study First Received: March 1, 2010
Last Updated: October 4, 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 27, 2017