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 Cardiology2025
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.
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, 2025. 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 37 papers, 1 of them a synthesis that pooled it.
What it found
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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
37 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pulsed field ablation for the interventional treatment of atrial fibrillation: a scientific statement of the European Heart Rhythm Association of the European Society of Cardiology, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, the Latin American Heart Rhythm Society, and the Canadian Heart Rhythm Society.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 · 2026Guideline
- 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
- Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX 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 · 2026Trial
- Wide-Antral pulmonary vein isolation in patients undergoing atrial fibrillation ablation with a Single-Shot technique: rationale and design of the WIDER-PVI trial.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Trial
- Catheter Design Matters: Hemolysis and Renal Function after Pulsed Field Ablation with Balloon-in-Basket vs. Pentaspline Systems.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Monitored anesthesia care versus general anesthesia for balloon-in-basket pulsed-field ablation of atrial fibrillation: an age-matched analysis of procedural timing and acute procedural outcomes.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
- Haemolysis and renal effects across pulsed field ablation systems in atrial fibrillation.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
- Versatility of the novel balloon-in-basket pulsed field ablation catheter: Pulmonary vein isolation and beyond.Heart rhythm O2 · 2026Article
- The Immune System as a Proarrhythmic Mediator: A Novel Paradigm for the Development of New Antiarrhythmic Therapy.The Canadian journal of cardiology · 2026Review
- Ablation of a persistent left superior vena cava using a balloon-in-basket pulsed field ablation catheter.HeartRhythm case reports · 2026Article
- "Awake but elsewhere": impact of augmented reality glasses on conscious sedation in balloon-in-basket pulsed field ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Safety and performance of the novel balloon-in-basket pulsed field ablation system: initial 100-patient experience at a high-volume electrophysiology center.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
- Pulmonary vein and left atrial posterior wall isolation using a balloon-in-basket pulsed-field ablation catheter via the superior vena cava approach in a patient with interrupted inferior vena cava: a case report.European heart journal. Case reports · 2026Article
- Hemolysis Profile of a Novel Balloon-Filled Basket Pulsed Field Ablation Catheter.Circulation. Arrhythmia and electrophysiology · 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
- 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
Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
aimsPulsed field ablation (PFA) is a growing ablation modality for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. This study assesses the 6-month safety and effectiveness of a novel balloon-in-basket, mapping-integrated PFA system, with a purpose-built form factor for PVI. METHODS AND
resultsThe VOLT CE Mark Study is a prospective, multi-center, pre-market study. A total of 150 patients with drug-refractory paroxysmal (PAF) or persistent AF (PersAF) were enrolled between 8 November 2023 and 14 March 2024, of which 146 patients (age 64.1 ± 10.0 years, 63.0% male, 70.5% PAF) underwent PVI with the balloon-in-basket PFA catheter and system featuring integrated electroanatomic mapping with contact-sensing. Study endpoints were the rate of primary serious adverse events within 7 days as well as acute procedural effectiveness and 6-month freedom from recurrence. Acute effectiveness was achieved in 99.1% (573/578) of treated PVs (98.6% of patients, 144/146) with 17.6 ± 5.7 PFA applications/patient. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 100.4 ± 33.0, 17.3 ± 12.1, 39.4 ± 20.6, and 31.4 ± 16.8 min, respectively. There were 4 (2.7%; 4/146) primary serious adverse events. The rate of freedom from documented atrial arrhythmias was 88.2% in PAF patients and 76.7% in PersAF patients (freedom from symptomatic recurrence was documented in 90.2% of PAF patients and 74.4% of PersAF patients) through 6-months post-index procedure.
conclusionThe VOLT CE Mark Study primary results demonstrate the safety and effectiveness of the novel balloon-in-basket PFA system to perform PVI in PAF and PersAF.
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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.