Safety and effectiveness of a novel balloon-in-basket pulsed-field ablation catheter for the treatment of paroxysmal and persistent AF: Volt-AF IDE trial acute results

Lo, M; Gambhir, A; Sundaram, S; Sanders, P; DeLurgio, D; Trivedi, A; Mountantonakis, S; Woods, C; Neuzil, P; Verma, A; Osca, J; Loh, P; Calkins, H; Strouse, D; Chierchia, GB; Atwater, B; Wenzel, E; Lin, W; Miller, A; Lakkireddy, D

doi:10.1016/j.hrthm.2025.04.037

Arrhythmias & electrophysiology

Safety and effectiveness of a novel balloon-in-basket pulsed-field ablation catheter for the treatment of paroxysmal and persistent atrial fibrillation (AF): Volt-AF Investigational Device Exemption (IDE) trial acute results

Heart RhythmPublished 26 Apr 2025Prospective single-arm IDE study

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Authors' conclusion

These results demonstrate the acute safety and effectiveness of a novel balloon-in-basket PFA catheter to treat paroxysmal and persistent AF.

Study context

Population: Symptomatic, drug-refractory paroxysmal AF (PAF) and persistent AF (PersAF) patients undergoing de novo PVI-only ablation with the Volt balloon-in-basket Pulsed Field Ablation (PFA) catheter57 roll-in, 335 primary analysis
Participants: 392 participants

Exposure: PAF vs PersAF
Outcome: Primary safety endpoint: device- or procedure-related SAE
Follow-up: Within 7 days

Methodological detailsglobal, 38 sites

Global
38 sites

Main finding

As reported in the abstract

Acute isolation

Group	Value	Veins isolated
PAF	98.2%	99.4% (666/670)
PersAF	99.4%	99.8% (633/634)

Value

PAF98.2%

PersAF99.4%

Veins isolated

PAF99.4% (666/670)

PersAF99.8% (633/634)

Observational data: associations, not effects.

Further findings

Applications per patient

Applications/patient: 18.5 ± 3.6

Fluoroscopy use

Procedural efficiency and acute outcomes did not differ with fluoroscopy use

Sedation vs general anesthesia

Conscious or deep sedation associated with increased procedural efficiency, no difference in acute success vs general anesthesia

Safety

Primary safety endpoint events (device- or procedure-related SAE within 7 days)

Primary safety endpoint events: 1.9%

Hemolysis or kidney injury

No clinically relevant hemolysis or kidney injury reported

Original publication

Safety and effectiveness of a novel balloon-in-basket pulsed-field ablation catheter for the treatment of paroxysmal and persistent AF: Volt-AF IDE trial acute results. Heart Rhythm. Published 26 April 2025. doi:10.1016/j.hrthm.2025.04.037

Read the original article ↗

Summarised from the published abstract; every number is checked against it