Arrhythmias & electrophysiology
Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility 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)
Methodological detailspre-market, multicentre, feasibility sub-study
- Pre-market
- Multicentre
- Feasibility sub-study
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.
Summarised from the published abstract; every number is checked against it