Trial reportCirculation2024
Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial.
Trial report in Circulation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05293639 (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System), which is not on this map. Cited by 85 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.
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)
Who cites it
85 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
- Incidence of silent cerebral lesions during pulsed field ablation for paroxysmal atrial fibrillation.Annals of medicine · 2026Trial
- 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
- Lesion Durability of the Second Generation Pentaspline Pulsed Field Ablation CatheterCirculation. Arrhythmia and electrophysiology · 2026Trial
- Pulsed field ablation versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study.Nature medicine · 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
- 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
- Procedural characteristics and clinical outcomes from same-day discharge after pulsed field ablation treatment for atrial fibrillation: an admIRE trial sub-analysis.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
- 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
- First-in-human trial of atrial fibrillation ablation using real-time tissue optical assessment to predict pulsed field lesion durability.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
- Optimal duration of anticoagulation after successful catheter ablation for atrial fibrillation: insights from recent randomized trials.Communications medicine · 2026Article
- Fluoroless Workflow for Pulsed Field Ablation of Atrial Fibrillation Using the Sphere-9 and VARIPULSE Catheters.Journal of clinical medicine · 2026Review
- Artificial intelligence-intracardiac echocardiography-guided pulsed field ablation of atrial fibrillation with 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 · 2026Article
- Context-dependent interactions between variable-loop pulsed field ablation and cardiac implantable electronic devices: a controlled preclinical study.European heart journal open · 2026Article
- Endoluminal Catheter Pulsed Field Ablation for the Treatment of Atherosclerotic Vascular Disease.Annals of biomedical engineering · 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
- Post-market individual-report phenotypes after pulsed-field ablation for atrial fibrillation in a food and drug administration database.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Concomitant Pulsed Field Ablation and Left Atrial Appendage Occlusion for Atrial Fibrillation With Dextrocardia.JACC. Case reports · 2026Article
- Pulsed Field Versus Cryoballoon Ablation for Atrial Fibrillation: Procedural Outcomes and Hemolysis-Related Laboratory Changes in a Single-Center Pilot Study.Medicina (Kaunas, Lithuania) · 2026Article
- Pulsed Field Ablation for Atrial Fibrillation: Mechanism, Clinical Evidence, and Emerging Applications.Cureus · 2026Review
25 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEvidence from clinical trials of early pulsed field ablation (PFA) systems in treating atrial fibrillation has demonstrated their promising potential to reduce complications associated with conventional thermal modalities while maintaining efficacy. However, the lack of a fully integrated mapping system, a staple technology of most modern electrophysiology procedures, poses limitations in lesion creation and workflow options. A novel variable-loop PFA catheter integrated with an electroanatomic mapping system has been developed that allows for real-time nonfluoroscopic procedural guidance and lesion indexing as well as feedback of tissue-to-catheter proximity. AdmIRE (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Bosense-Webster Irreversible Electroporation Ablation System), a multicenter, single-arm, Food and Drug Administration investigational device exemption study, evaluated the long-term safety and effectiveness of this integrated PFA system in a large United States-based drug-refractory symptomatic paroxysmal atrial fibrillation patient population.
methodsUsing the PFA catheter with a compatible electroanatomic mapping system, patients with drug-refractory symptomatic paroxysmal atrial fibrillation underwent pulmonary vein isolation. The primary safety end point was primary adverse event within 7 days of ablation. The primary effectiveness end point was a composite end point that included 12-month freedom from documented atrial tachyarrhythmia (ie, atrial fibrillation, atrial tachycardia, atrial flutter) episodes, failure to achieve pulmonary vein isolation, use of a nonstudy catheter for pulmonary vein isolation, repeat procedure (except for one redo during blanking), taking a new or previously failed class I or III antiarrhythmic drug at higher dose after blanking, or direct current cardioversion after blanking.
resultsAt 30 centers, 277 patients with paroxysmal atrial fibrillation (61.5±10.3 years of age; 64.3% male) in the pivotal cohort underwent PFA. More than 25% of the procedures were performed without fluoroscopy. Median (Q1, Q3) pulmonary vein isolation procedure, fluoroscopy, and transpired PFA application times were 81.0 (61.0, 112.0), 7.1 (0.00, 14.3), and 31.0 (24.8, 40.9) minutes, respectively. The primary adverse event rate was 2.9% (8 of 272), with the most common complication being pericardial tamponade. The 12-month primary effectiveness end point was 74.6%. The 1-year freedom from atrial fibrillation, atrial tachycardia, or atrial flutter recurrence rate after blanking was 75.4%. Substantial improvements in quality of life were observed as early as 3 months after the procedure, concurrent with a reduction in multiple health care use measures.
conclusionsAdmIRE confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05293639.
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