Arrhythmias & electrophysiologyCohort study
Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study
- Prospective single-arm feasibility study
- pre-market
- multicentre
- feasibility sub-study
Authors' conclusion
The initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.
Study context
- Population
- Patients with paroxysmal or persistent atrial fibrillation (AF)all completed 30-day follow-up
- Participants
- 32 patients
- Outcome
- Primary serious adverse event rate and acute procedural effectiveness
- Follow-up
- Within 7 days (serious adverse events)
Main finding
As reported in the abstract
Acute procedural effectiveness · acute
Acute effectiveness, treated pulmonary vein (PVs) (127/128)
99.2%
Acute effectiveness, subjects (31/32)
96.9%
Observational data: associations, not effects.
Further findings
Procedural metrics
- Pulsed field ablation (PFA) applications/subject (mean ± SD)
- 23.8 ± 4.2
- Procedure time, min
- 124.6 ± 28.1
- Fluoroscopy time, min
- 19.8 ± 8.9
- LA dwell time, min
- 53.0 ± 21.0
- Transpired ablation time, min
- 48.0 ± 19.9
Safety
Primary serious adverse events · within 7 days
- No primary serious adverse events
Systematic safety assessments
- Silent cerebral lesions (3 subjects)
- 9.4%
- No phrenic nerve injury, PV stenosis or oesophageal lesions causally related to the PFA system
Original publication
Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study. Europace. Published 3 May 2024. doi:10.1093/europace/euae118
Summarised from the published abstract; every number is checked against it