Atrial Fibrillation
Conditions
Keywords
paroxysmal atrial fibrillation, persistent atrial fibrillation, high burden of atrial fibrillation, atrial fibrillation ablation, Pulmonary vein isolation, AF trigger, complex fractionated electrograms, CFE, CFAE, complex fractionated atrial electrograms, refractory antiarrhythmic medication, PVAI, Ensite NavX, NavX, CoolPath catheter, irrigated ablation catheter, high burden of paroxysmal or persistent atrial fibrillation, candidates for AF ablation, symptomatic AF, AF is refractory to at least one antiarrhythmic medication
Brief summary
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (\>4 episodes within 6 months, two episodes \>6 hours within 1 year) or persistent (sustained episode \<6 months terminated by cardioversion or drug). Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation
Detailed description
Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation (trigger) or ablation of high-frequency, fractionated electrograms during AF (substrate), or a hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted. Outcomes: * Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months post-initial procedure. * Recurrence will be defined by symptoms and/or ECG/Holter data showing AF \> 2 mins * Occurrence of adverse events in each group post-procedure. * Quality of life assessment at 6 and 12 months post-initial procedure. Followup: * 3, 6, and 12 months post-initial procedure. * Clinical data, ECG, Holter, loop recorder at baseline and at each visit. * QOL at baseline, 3, 6 and 12 months post-initial procedure.
Interventions
PROCEDUREAblate AF triggers via PVI
Trigger-based ablation guided by pulmonary vein antrum isolation
PROCEDURESubstrate via CFAEs
Substrate-based ablation using an approach targeting CFAEs
PROCEDURECombined approach for AF ablation
Combined trigger and substrate based approach
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients age 18 or greater. * high burden of paroxysmal atrial fibrillation or 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
* chronic 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 or spontaneous echo contrast on TEE prior to procedure. * contraindications to systemic anticoagulation with heparin or coumadin. * previously undergone atrial fibrillation ablation. * left atrial size \> 55 mm. * Patients who are or may potentially be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications. | 12 months |
| Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death. | 12 months |
| Procedure duration at ablation. | At intervention |
| Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure. | 12 months |
| Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure. | 12 months |
| Fluoroscopy time at ablation. | At intervention |
| Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure. | 12 months |
Countries
Canada, Italy, Norway, Spain
Outcome results
None listed