ArticleEuropace : 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
Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study.
Article 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 trial NCT05072964 (The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation), which is not on this map. Cited by 32 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.
The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Pulsed field ablation for atrial fibrillation: a comprehensive bibliometric analysis of research trends and emerging Frontiers.Frontiers in cardiovascular medicine · 2025Pooled it
- Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF 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 · 2024Trial
- First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for 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 · 2024Trial
- Characteristics of Recurrent Atrial Arrhythmias and Lesion Assessment Late After Pulsed Field Ablation of Atrial Fibrillation.Circulation. Arrhythmia and electrophysiology · 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
- Pulsed Field Ablation with the Pentaspline Catheter vs Radiofrequency Ablation for Recurrent Atrial Fibrillation.CJC open · 2026Article
- Single-shot ablation for AF: Real-world procedural and one-year outcomes with the newly adopted PulseSelect PFA compared with cryoballoon from the 1STOP project.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Pulsed field ablation of a persistent left superior vena cava triggering atrial fibrillation: A case report.HeartRhythm case reports · 2026Article
- Incidence and predictors of AF recurrence during long-term follow-up of patients after PF ablation for 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
- Pulsed field ablation: from technological breakthrough to structured clinical implementation-the role of the European Heart Rhythm Association.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
- Workflow and sedation choice with the PFA variable-loop circular catheter in real-world AF procedures: insights from the prospective multi-centre VARIPURE clinical 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
- A case report of persistent phrenic nerve injury following pulsed field ablation using a pentaspline catheter.European heart journal. Case reports · 2026Article
- Coronary Spasm Due to Pulsed Field Ablation: A State-of-the-Art Review.Pacing and clinical electrophysiology : PACE · 2026Review
- Gastroparesis as a potential complication of pentaspline pulsed field ablation without endoscopic esophageal injury.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Review
- Catheter ablation of arrhythmias: 15 years of development: data from the Swedish Catheter Ablation Registry.European heart journal open · 2025Article
- Comparison of Two Different Pulsed Field Ablation Systems: The Dual Pulse System Study.Journal of cardiovascular electrophysiology · 2025Article
- The Efficacy of 2-Week Holter Monitoring for Detecting Atrial Tachyarrhythmia Recurrence After Initial Ablation in Patients With Atrial Fibrillation.Journal of arrhythmia · 2025Article
- Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-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 · 2025Article
- Pulsed-Electrical Field Ablation Completes Pulsed-Field Ablation-Lessons Learned on Tissue Proximity Indication in Pulmonary Vein Isolation.Journal of cardiovascular electrophysiology · 2025Article
Corrections and comments
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Authors and funding
17 authors at 13 institutions in 7 countries.
Funding
Abstract
aimsPulmonary vein isolation (PVI) is a well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing the promise of pulsed-field ablation (PFA) for this treatment, long-term efficacy and safety data demonstrating single-procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF. METHODS AND
resultsFARA-Freedom, a prospective, non-randomized, multicentre study, enrolled patients with PAF undergoing de novo PVI with PFA, who were followed for 12 months with weekly transtelephonic monitoring and a 72-h Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success, which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time. The study enrolled 179 PAF patients (62 ± 10 years, 39% female) at 13 centres. At the index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20-min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high, with 88.4 and 90.3% with weekly events and 72-h Holter monitors, respectively. Freedom from the composite primary effectiveness endpoint was 66.6%, and 41 patients had atrial tachyarrhythmia recurrence, mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE fistula. There were four cases of transient phrenic nerve palsy, but all resolved during the index procedure.
conclusionIn this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety. REGISTRATION: Clinical Trials.gov Identifier: NCT05072964 (sponsor: Boston Scientific Corporation).
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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.