New findings from Abbott‘s Volt CE Mark Study demonstrate that patients undergoing pulsed field ablation (PFA) therapy with the Volt™ PFA System for treating atrial fibrillation (AFib) have excellent safety and efficacy for up to 12 months. The research also demonstrates the Volt PFA System’s superior safety profile and its capacity to provide outcomes with fewer therapeutic applications than competing PFA systems currently on the market.
In contrast to conventional cardiac ablation techniques, PFA therapy targets specific cardiac tissue regions with high-energy electrical pulses that result in irregular heartbeats. To evaluate the effectiveness of the Volt PFA System in two distinct patient groups, those suffering from paroxysmal atrial fibrillation (PAF) Abbott created the Volt CE Mark Study.
The Volt CE Mark Study’s 12-month data were simultaneously published in Heart Rhythm, the Heart Rhythm Society’s official publication, and presented at the 2025 Heart Rhythm Society (HRS) annual meeting, which took place in San Diego from April 24-27, 2025.
Data from the Volt CE Mark Study
- For patients with PAF and PersAF, the Volt PFA System showed consistent performance in terms of safety and efficacy for up to 12 months.
- Among the lowest rates of recurrence in PAF patients in a long-term PFA study to date, 83.5% of PAF patients and 58.1% of PersAF patients were still free of atrial arrhythmia after a year.
- With QoL assessment scores rising from 64.1 to 88.1 after a year, the Volt CE Mark Study demonstrated a noteworthy improvement in patients’ quality of life.
- Only 2.7% of Volt patients experienced a primary safety endpoint event after a year, and none of them had any of the potential side effects of PFA therapy, including hemolysis (the destruction of red blood cells), coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury.
The long-term 12-month results from the Volt CE Mark Study paint a picture of a PFA system that performs exceptionally well in two different groups of patients – each with unique therapy needs and clinical approaches,
These long-term data provide us a strong picture of how the Volt PFA System will perform in clinical settings as we leverage PFA therapy for our patients.
Prof. Gian-Battista Chierchia
In order to serve as many patients as possible, clinical experience after CE Mark has so far further validated that the Volt PFA System can support treating patients who are facing either PAF or PersAF. Additionally, the Volt PFA System offers a single-catheter PFA method, enhances efficiency, and offers procedural flexibility by permitting either general anesthesia or light sedation. When comparing procedures carried out under conscious or deep sedation to those carried out under general anesthesia, a recent sub-analysis from the VOLT-AF IDE Study, which was presented at HRS 2025, revealed no discernible differences in safety or acute effectiveness outcomes.
Our goal from the beginning with the Volt PFA System was to design a PFA system that would provide outstanding results in patients battling a range of atrial arrhythmias, and the latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way.
Christopher Piorkowski
The purpose of Abbott’s prospective, single-arm, non-randomized, multicenter Volt CE Mark Study is to show that the Volt PFA System is safe and effective in treating recurrent, symptomatic, drug-refractory PAF and PersAF. In addition to enrolling 150 patients at 11 locations throughout Europe, the study also included a feasibility sub-study that gathered more imaging data to verify the Volt PFA System’s acute safety.
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