Abbott has announced promising 12-month data from its Volt CE Mark Study, demonstrating strong long-term safety and efficacy outcomes for patients receiving pulsed field ablation (PFA) therapy with the Volt™ PFA System for atrial fibrillation (AFib). The findings were presented at the 2025 Heart Rhythm Society (HRS) annual meeting in San Diego and simultaneously published in the journal Heart Rhythm.
The multicenter study evaluated the Volt PFA System in both paroxysmal atrial fibrillation (PAF) patients, who experience episodes that come and go, and persistent AFib (PersAF) patients, whose episodes last longer than seven days. The data highlights the system's ability to achieve results with fewer therapy applications—just 4.7 applications per vein on average—compared to competitive PFA systems currently on the market.
Strong Clinical Outcomes at 12 Months
The Volt CE Mark Study demonstrated impressive results across several key metrics after one year of follow-up:
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Freedom from arrhythmia: 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia at the 12-month mark, representing one of the lowest rates of recurrence in PAF patients reported in a long-term PFA study to date.
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Quality of life improvements: Patients experienced significant quality of life benefits, with assessment scores improving substantially from 64.1 to 88.1 over the 12-month period.
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Exceptional safety profile: Only 2.7% of patients experienced a primary safety endpoint event, with zero cases of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury—all potential complications associated with PFA therapy.
Prof. Gian-Battista Chierchia, director of the Atrial Fibrillation Program at the Heart Rhythm Management Institute at the University of Brussels in Belgium, commented on the findings: "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."
How PFA Therapy Works
Unlike traditional cardiac ablation approaches, PFA therapy delivers high-energy electrical pulses to targeted areas of cardiac tissue causing abnormal heart rhythms. This mechanism allows for effective treatment while potentially reducing certain risks associated with conventional ablation techniques.
The Volt PFA System offers a single-catheter approach, which may improve workflow efficiency during procedures. Additionally, it provides procedural flexibility by allowing for either light sedation or general anesthesia. A new sub-analysis from the VOLT-AF IDE Study, also presented at HRS 2025, showed no significant difference in safety or acute effectiveness outcomes between cases performed under conscious or deep sedation compared to procedures performed with general anesthesia.
Study Design and Methodology
The Volt CE Mark Study was designed as a prospective, single-arm, non-randomized, multicenter study to demonstrate the safety and effectiveness of the Volt PFA System for treating symptomatic, recurrent, drug-refractory PAF and PersAF. The study enrolled 150 patients across 11 European sites and included a feasibility sub-study with additional imaging assessments to confirm the acute safety of the system.
Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business, emphasized the company's vision: "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."
Clinical Implications
The positive results from the Volt CE Mark Study suggest that Abbott's Volt PFA System could offer an important treatment option for the millions of patients worldwide suffering from atrial fibrillation. AFib affects approximately 33 million people globally and is associated with significant morbidity, including increased risk of stroke, heart failure, and reduced quality of life.
The system's demonstrated effectiveness in both PAF and PersAF patients is particularly noteworthy, as persistent AFib has traditionally been more challenging to treat effectively. The ability to achieve high rates of freedom from arrhythmia with a favorable safety profile could potentially expand treatment options for patients who have not responded adequately to medication or who are seeking alternatives to traditional ablation approaches.
Clinical experience following CE Mark approval has further confirmed the Volt PFA System's versatility in treating both PAF and PersAF patients, potentially broadening its clinical utility and impact on patient care.
