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

Korea University

Status: Withdrawn

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: radiofrequency catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01088126

AN09239

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Focal ablation

Active Comparator group

Description:

PV isolation + CFAE-targeted focal ablation

Treatment:

Procedure: radiofrequency catheter ablation

Linear ablation

Active Comparator group

Description:

PV isolation + CFAE-guided linear ablation

Treatment:

Procedure: radiofrequency catheter ablation