Arrhythmias & electrophysiologyResearch article
Balloon-in-Basket Pulsed Field Ablation for Pulmonary Vein Isolation
- multicenter VOLT-AF IDE Clinical Study
Authors' conclusion
This multicenter trial reports high PVI-based effectiveness of the novel balloon-in-basket PFA device with excellent safety.(VOLT-AF IDE Clinical Study; NCT06223789).
Study context
- Population
- Patients with symptomatic, paroxysmal (PAF), and persistent atrial fibrillation (AF) (persistent AF (PeAF)) undergoing pulmonary vein isolation with a balloon-in-basket pulsed field ablation (PFA) systemenrolled, 335 main cohort patients (57 roll-ins), 320 treated · PAF (treated) 165 · PeAF (treated) 155
- Participants
- 392 patients
- Comparison
- PAF vs PeAF
- PAFn = 165
- PeAFn = 155
- Outcome
- Primary effectiveness: acute pulmonary vein isolation (PVI) and freedom from atrial arrhythmia, antiarrhythmic escalation/initiation, cardioversion, or repeat ablation
- Follow-up
- 12 months
Main finding
As reported in the abstract
Further findings
Freedom from documented arrhythmia recurrence
Baseline characteristics
- Mean age
- 65 ± 11 years
- Mean CHA2DS2-VASc score
- 2.3 ± 1.6
Procedural characteristics
- Left atrial catheter dwell time (including a 20-minute wait)
- 44.1 ± 18.1 minutes
- Mean applications delivered per vein
- 4.6 ± 0.9
Durable pulmonary vein isolation during redo ablation (19 patients)
- Pulmonary veins remaining durably isolated, among 19 patients with redo ablation
- 78.5%
Safety
| Outcome | PAF | PeAF |
|---|---|---|
| Primary safety endpoint: device- and/or procedure-related serious adverse events within 7 days of any ablation | none events | Not reported in the abstract |
- Primary safety endpoint: device- and/or procedure-related serious adverse events within 7 days of any ablation — Primary safety events, all patients
- 1.9%
Original publication
Balloon-in-Basket Pulsed Field Ablation for Pulmonary Vein Isolation. JACC Clin Electrophysiol. Published 5 February 2026. doi:10.1016/j.jacep.2026.01.006
Summarised from the published abstract; every number is checked against it