12-Month Safety and Effectiveness of a Balloon-in-Basket PFA System for De Novo PVI to Treat PAF and PsAF: Results from the VOLT-AF IDE Study

Abstract

Introduction Objectives: A balloon-in-basket PFA system underwent clinical investigation to demonstrate safety and effectiveness for treatment of symptomatic, drug-refractory, paroxysmal (PAF) and persistent AF (PsAF). This is the first report of 12-month data from the VOLT-AF IDE study. Method(s): The VOLT-AF IDE study (NCT06223789) is a global pre-market, prospective, single-arm clinical study. Primary analysis included 320 subjects who underwent de novo PVI using VoltTM PFA System and completed follow-up through 12-months post-procedure. Result(s): Of 320 subjects who underwent ablation, 165 (age 62.7 +/- 11.2 years, 61.2% male) and 155 (mean age 67.5 +/- 10.3 years, 68.4% male) were treated for PAF or PsAF, respectively. Primary safety endpoint event rate was 1.9% and included 1 vascular access complication, 2 cardiac tamponade, 1 pericarditis, 1 stroke, and 1 prolonged hospitalization event. Freedom from documented arrhythmia recurrence through 12-months was 84.2% and 67.8% in PAF and PsAF subjects, respectively (Figure 1). Recurrence was defined as arrhythmia episodes > 30 s after a 90-day blanking period following index ablation procedure detected by Transtelephonic monitoring, 12-lead ECG, and/or 24-h Holter monitoring. A total of 17 repeat ablations (17/320;5.3%) occurred after blanking period (5/165;3.0% PAF and 12/155;7.7% PsAF). In subjects who underwent repeat ablation after blanking period, 78.6% of treated PVs remained durably isolated with no PV reconnection. AF Effect on Quality-of-Life Survey (AFEQT) indicated significant (p < 0.0001) improvement in scores from baseline through 12-months of follow-up in PAF and PsAF populations. Conclusion(s): The 12-month results of the VOLT-AF IDE Study, including low primary safety endpoint event rate, low arrhythmia recurrence rate through 12-months of follow-up, and low repeat procedure rate combined with significant improvement in quality-of-life confirm safety and effectiveness of PVI performed with balloon-in-basket PFA system for treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation. Hypothesis testing confirmed success of VOLT-AF IDE study as safety and effectiveness endpoints were met for PAF and PsAF (Figure presented).