Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2024
Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study.
Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
VOLT CE Mark Study
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"
Who cites it
23 citing papers in PubMed.
- Pulmonary vein isolation durability in a randomized trial comparing fluoroscopy-only vs. electroanatomic mapping strategies for pulmonary vein isolation with balloon-in-basket pulsed-field ablation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Trial
- First-in-human experience from RESET-AF (Rapid onE-Shot Electroporation Trial for Atrial Fibrillation).Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Trial
- Impact of saline irrigation on haemolysis, silent cerebral lesion incidence, thermal dynamics, and bubble formation in pulsed field ablation with a variable-loop circular catheter.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Trial
- Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Trial
- Head-to-head comparison of pulsed-field ablation, high-power short-duration ablation, cryoballoon and conventional radiofrequency ablation by MRI-based ablation lesion assessment.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Standardised superior vena cava isolation with a balloon-in-basket pulsed-field ablation catheter: feasibility and acute safety of two procedural workflows in 53 consecutive patients.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Impact of a balloon-in-basket pulsed field ablation catheter on oesophageal temperature changes during pulmonary vein isolation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Pulmonary vein isolation using a novel balloon-in-basket pulsed field ablation system: The Lübeck how-to protocol.Heart rhythm O2 · 2026Article
- Adjunctive posterior wall ablation with a balloon-in-basket pulsed-field ablation catheter in atrial fibrillation: feasibility, safety, and insights into targeted lesion delivery from the VOLT CE Mark study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Evaluation of a Novel Multielectrode Surgical Pulsed Field Ablation Clamp: An Ex-Vivo Vegetal Study.Interdisciplinary cardiovascular and thoracic surgery · 2026Article
- Superior vena cava isolation with 3D mapping using a novel balloon-in-basket pulsed field ablation catheter.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- How to isolate the superior vena cava using balloon-in-basket pulsed field ablation system: Standardized workflow and initial results.Heart rhythm O2 · 2026Article
- "Awake and Ablated": First experience with a balloon-in-basket PFA system without propofol.Heart rhythm O2 · 2026Article
- Does sex shape the biological footprint of balloon-in-basket pulsed field ablation-guided pulmonary vein isolation? A biomarker analysis.Frontiers in cardiovascular medicine · 2026Article
- Latest Advances and Ongoing Challenges in Pulsed Field Ablation.Arrhythmia & electrophysiology review · 2026Review
- Uniform and Complete Irreversible Electroporation on Gastric Mucosa Enabled by Sintered Silver Hydrogel.Cyborg and bionic systems (Washington, D.C.) · 2026Article
- Pulse Field Ablation: An Update on Energy-Specific Adverse Events.Reviews in cardiovascular medicine · 2025Review
- Esophageal endoscopic findings after pulmonary vein and posterior wall isolation using pulsed field ablation: results from the Eso-PFA study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Observational
- Catheter ablation using pulsed-field energy: Advantages and limitations compared with conventional energy.Journal of arrhythmia · 2025Review
- Balloon vs. balloon-comparison of hemolysis and renal markers after cryoballoon vs. ballon-in-basket pulsed field pulmonary vein isolation.Frontiers in cardiovascular medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
aimsPulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) potentially offers improved safety and procedural efficiencies compared with thermal ablation. Opportunities remain to improve effective circumferential lesion delivery, safety, and workflow of first-generation PFA systems. In this study, we aim to evaluate the initial clinical experience with a balloon-in-basket, 3D integrated PFA system with a purpose-built form factor for pulmonary vein (PV) isolation. METHODS AND
resultsThe VOLT CE Mark Study is a pre-market, prospective, multi-centre, single-arm study to evaluate the safety and effectiveness of the Volt™ PFA system for the treatment of paroxysmal (PAF) or persistent AF (PersAF). Feasibility sub-study subjects underwent phrenic nerve evaluation, endoscopy, chest computed tomography, and cerebral magnetic resonance imaging. Study endpoints were the rate of primary serious adverse event within 7 days and acute procedural effectiveness. A total of 32 subjects (age 61.6 ± 9.6 years, 65.6% male, 84.4% PAF) were enrolled and treated in the feasibility sub-study and completed a 30-day follow-up. Acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 124.6 ± 28.1, 19.8 ± 8.9, 53.0 ± 21.0, and 48.0 ± 19.9 min, respectively. Systematic assessments of initial safety revealed no phrenic nerve injury, pulmonary vein stenosis, or oesophageal lesions causally related to the PFA system and three subjects with silent cerebral lesions (9.4%). There were no primary serious adverse events.
conclusionThe initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.