Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 107
- Locations
- 16
- Primary Endpoint
- Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
PVI group
Trigger-based ablation guided by pulmonary vein antrum isolation
Intervention: Ablate AF triggers via PVI (Procedure)
CFAE group
Substrate-based ablation using an approach targeting CFAEs
Intervention: Substrate via CFAEs (Procedure)
Combined group
Combined trigger and substrate based approach
Intervention: Combined approach for AF ablation (Procedure)
Outcomes
Primary Outcomes
Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
Time Frame: 3 months
Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.
Time Frame: 12 months
Secondary Outcomes
- Fluoroscopy time at ablation.(At intervention)
- Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.(12 months)
- Procedure duration at ablation.(At intervention)
- Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.(12 months)
- Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.(12 months)
- Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.(12 months)