Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation
Not Applicable
Withdrawn
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Procedure: radiofrequency catheter ablation
- Registration Number
- NCT01088126
- Lead Sponsor
- Korea University Anam Hospital
- 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 available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Focal ablation radiofrequency catheter ablation PV isolation + CFAE-targeted focal ablation Linear ablation radiofrequency catheter ablation PV isolation + CFAE-guided linear ablation
- Primary Outcome Measures
Name Time Method freedom from AF/AT more than 3 months after first ablation 12 months
- Secondary Outcome Measures
Name Time Method freedom from AF/AT within 3 months following first ablation 3 months procedure time 12 months acute intra-procedure termination of AF 12 months organization of AF/conversion to AT during the ablation 12 months ablation time 12 months procedure-related complication 12 months
Trial Locations
- Locations (1)
Korea University Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Medical Center🇰🇷Seoul, Korea, Republic of