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
First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation.
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 19 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.
A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
A Safety and Performance Assessment of the SpherePVI™ Catheter and the Affera Mapping and Ablation System to Treat Paroxysmal Atrial Fibrillation
Who cites it
19 citing papers in PubMed.
- Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial.Circulation · 2024Trial
- Pulsed Field Ablation Therapy Parameters: Enhancing Lesion Depth While Reducing Musculoskeletal Stimulation and Thermal Response in an Irrigated Tip Catheter: A Comprehensive Study Using In Silico, In Vitro, and In Vivo Models.Circulation. Arrhythmia and electrophysiology · 2026Article
- Pulse field ablation in patients with paroxysmal and persistent atrial fibrillation using the circular multielectrode array catheter: first outcome data in a real-world prospective study.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- 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
- Comparison of general anesthesia and deep sedation for complex atrial ablation procedures using a lattice-tip catheter with monopolar pulsed field and radiofrequency ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- A network meta-analysis of comparative effectiveness and safety of pulsed field, radiofrequency, and cryoballoon ablation for atrial fibrillation.Heart rhythm O2 · 2026Article
- Efficacy and safety of a novel pulsed field ablation system in paroxysmal atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- A Review of Potential Complications of Pulsed Field Ablation for AF: Beneath the Surface.Arrhythmia & electrophysiology review · 2026Review
- Microbubble Formation and Hemolysis in Pulsed Field Ablation for Treating Arrhythmia: Risks, Mechanisms, and Prevention.Pacing and clinical electrophysiology : PACE · 2026Review
- Sleep Disorders and Perioperative Stroke: A Global Bibliometric Analysis from 1999 to 2024.Nature and science of sleep · 2026Article
- Atrial fibrillation: from pathogenesis to novel treatment options.Molecular biomedicine · 2025Review
- Lesion Durability Using a Circular Pulsed Field Ablation Catheter and Novel Mapping-Navigation System.Circulation. Arrhythmia and electrophysiology · 2025Article
- Pulsed-field ablation beyond pulmonary vein for persistent atrial fibrillation: efficacy and impact on left atrial function.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025Article
- Thermal and Non-Thermal Energies for Atrial Fibrillation Ablation.Journal of clinical medicine · 2025Review
- Catheter ablation using pulsed-field energy: Advantages and limitations compared with conventional energy.Journal of arrhythmia · 2025Review
- Catheter Ablation in Atrial Fibrillation: Recent Advances.Journal of clinical medicine · 2024Review
- General anaesthesia and deep sedation for monopolar pulsed field ablation using a lattice-tip catheter combined with a novel three-dimensional mapping system.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 · 2024Article
- Application repetition and electrode-tissue contact result in deeper lesions using a pulsed-field ablation circular variable loop 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 · 2024Article
- A large footprint focal catheter toggling between pulsed field and radiofrequency energy: first clinical experience for ventricular tachycardia 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 · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
aimsPulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. METHODS AND
resultsAfter rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort.
conclusionPulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.
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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.