Arrhythmias & electrophysiology
Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results
Authors' conclusion
The VOLT CE Mark Study primary results demonstrate the safety and effectiveness of the novel balloon-in-basket PFA system to perform PVI in PAF and PersAF.
Study context
- Population
- Patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI) with a balloon-in-basket pulsed field ablation (PFA) system146 underwent PVI
- Participants
- 150 patients
- Exposure
- PAF vs persistent AF (PersAF)
- Outcome
- Freedom from documented atrial arrhythmias
- Follow-up
- 6 months
Methodological detailsmulticentre, pre-market
- Multicentre
- Pre-market
Main finding
As reported in the abstract
Freedom from documented atrial arrhythmias · 6 months
Freedom from symptomatic recurrence
- Acute effectiveness, treated PVs
- 99.1% (573/578)
- Acute effectiveness, patients
- 98.6% (144/146)
Observational data: associations, not effects.
Further findings
Procedural metrics
- PFA applications/patient
- 17.6 ± 5.7
- Procedure time (min)
- 100.4 ± 33.0
- Fluoroscopy time (min)
- 17.3 ± 12.1
- LA dwell time (min)
- 39.4 ± 20.6
- Transpired ablation time (min)
- 31.4 ± 16.8
Safety
Primary serious adverse events · within 7 days
- Primary serious adverse events
- 4 (2.7%; 4/146)
Original publication
Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results. Europace. Published 31 March 2025. doi:10.
Summarised from the published abstract; every number is checked against it