Evidence map›Paper›PMID 40888735›Full record

Observational studyEuropace : 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

Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry.

Lucas V A Boersma, Gábor Széplaki, Antonio Dello Russo, Ignacio García-Bolao, Michael Efremidis, Nándor Szegedi, Stephan Willems, Haris Haqqani, Estelle Gandjbakhch, Francesco Solimene and 17 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study 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 trial NCT05501873 (Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT05501873 active not recruitingnot on this map

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

Typeobservational_patient_registrySponsorBoston Scientific CorporationRan2023 to 2027Enrolled1,173ConditionsAtrial FibrillationArmsFARAPULSE Pulsed Field Ablation system
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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 · 2026
    Guideline
  3. 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 · 2026
    Trial
  4. Pulsed-field ablation for atrial fibrillation with an extended protocol: the extended PFA dose 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 · 2026
    Article
  5. Procedural Management of Atrial Fibrillation in Older Patients.Reviews in cardiovascular medicine · 2026
    Review
  6. Pulmonary vein reconnection patterns after pentaspline pulsed field 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 · 2026
    Article
  7. Optimized workflow for pentaspline PFA and its impact on PVI durability: evidence from systematic remapping.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 · 2026
    Article
  8. Effectiveness of AF pulsed field ablation with a variable-loop circular catheter: 12-month VARIPURE 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 · 2026
    Article
  9. Review
  10. 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 · 2026
    Article
  11. 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 · 2026
    Article
  12. 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 · 2026
    Article
  13. Article
  14. Review
  15. Assessment of temperature dynamics in pulsed field ablation with a variable-loop circular catheter: a comparative analysis of waveform configurations and irrigation rates in specimens of bovine ventricular myocardium.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
    Article
  16. Repeat ablation for persistent atrial fibrillation: what lies beyond lines and veins?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
    Article
  17. Another day in FARADISE? Lessons learned from a real-world global registry of pulsed field ablation with the pentaspline catheter for atrial fibrillation 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 · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Lucas V A BoersmaCardiology Department, St. Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands.ORCID 0000-0003-4591-4220
Gábor SzéplakiMater Private Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.ORCID 0000-0003-3795-1240
Antonio Dello RussoBiomedical Science and Public Health Department, Polytechnic University of Marche, AOUM Hospital, Ancona, Italy.ORCID 0000-0001-7737-421X
Ignacio García-BolaoUniversity Clinic of Navarra, Navarra, Spain.ORCID 0000-0002-8544-7324
Michael EfremidisOnassis Cardiac Surgery Center, Kallithea, Greece.
Nándor SzegediHeart and Vascular Center, Semmelweis University, Budapest, Hungary.ORCID 0000-0001-5670-745X
Stephan WillemsAsklepios Clinic St. Georg, Hamburg, Germany.ORCID 0000-0002-8890-5749
Haris HaqqaniPrince Charles Hospital, Chermside, Queensland, Australia.ORCID 0000-0003-1543-6686
Estelle GandjbakhchSorbonne Université, APHP, Hospital La Pitié Salpetrière, Paris, France.ORCID 0000-0002-4846-5021
Francesco SolimeneCasa di Cura Montevergine SPA, Mercogliano, Italy.ORCID 0000-0003-4179-9050
George AndrikopoulosHenry Dunant Hospital Center, Athens, Greece.ORCID 0000-0001-7852-884X
Martin FialaNeuron Medical, Brno, Czech Republic.
Pascal DefayeCHU Grenoble-Hopital Michallon, Grenoble, France.ORCID 0000-0002-7183-4278
Armin LuikStaedtisches Klinikum Karlsruhe, Karlsruhe, Germany.ORCID 0000-0001-5926-6696
Patrick LugenbielDepartment of Cardiology, Medical University Hospital Heidelberg, Heidelberg, Germany.ORCID 0000-0003-3886-0930
Lars EckardtDepartment of Cardiology-Electrophysiology, University Hospital of Münster, Münster, Germany.ORCID 0000-0002-3735-8503
Alexandre OussCatharina Ziekenhuis, Eindhoven, The Netherlands.ORCID 0000-0001-7405-822X
Jean-Manuel HerzetCentre Hospitalier Régional de la Citadelle, Liège, Belgium.ORCID 0009-0002-7087-6860
Javier Ramos MaquedaHospital Clinico Universitario Lozano Blesa, Zaragoza, Spain.
Sélim AbbeyHopital Prive du Confluent, Nantes, France.
Joaquín OscaHospital Universitario y Politécnico La Fe, Valencia, Spain.ORCID 0000-0002-7253-1826
Azlan HussinInstitut Jantung Negara, Kuala Lumpur, Malaysia.
Nele CielenBoston Scientific, St. Paul, MN, USA.
Madeline JohnsonBoston Scientific, St. Paul, MN, USA.ORCID 0000-0001-7524-2846
Elizabeth M AlbrechtBoston Scientific, St. Paul, MN, USA.
Brad S SuttonBoston Scientific, St. Paul, MN, USA.
Johan VijgenJessa Hospital, Hasselt, Belgium.ORCID 0000-0003-4928-4836

Funding

Boston Scientific
6 · The paper itself

Abstract

aimsClinical studies with protocol-mandated workflow and monitoring have analysed performance of pulsed field ablation (PFA) for treating atrial fibrillation (AF). The FARADISE registry captures global use of the pentaspline PFA catheter in real-world clinical practice with a follow-up of 3 years. METHODS AND

resultsFARADISE is a prospective, non-randomized, multi-national registry (NCT05501873) that enrolled subjects clinically indicated for ablation using the pentaspline PFA catheter per medical judgement and hospital standard-of-care. Procedural characteristics, safety, and clinical effectiveness up to 12-months were collected. In total, 1158 AF patients received PFA across 48 centres in 21 countries (64 ± 11 years, 33% female, 90% de novo, 65% paroxysmal AF). Pulmonary vein isolation (PVI)-only procedures were performed in 80.8% of paroxysmal vs. 57.5% for non-paroxysmal patients (P < 0.01). Median procedure, left atrial dwell, and fluoroscopy times were 51[40-70], 31[24-41], and 12[8-17] min, respectively. The rate of early onset serious adverse events was 1.5% and did not differ by ablation strategy or AF indication. At 1-year, clinical effectiveness was 80.8% for paroxysmal AF and 67.7% for non-paroxysmal AF, with no difference within indication by lesion set (paroxysmal: 81.2% PVI-only vs. 79.0% PVI+, P = 0.65; non-paroxysmal: 67.5% PVI-only vs. 67.7% PVI+, P = 0.79). Acute results reinforce a short procedural learning curve with no difference in 1-year effectiveness by operator experience.

conclusionThe FARADISE registry provides a snapshot of real-world clinical use of the pentaspline PFA catheter. Acute results demonstrate favourable procedural and safety outcomes regardless of AF indication. One-year outcomes are encouraging, with no differences seen within indication based on ablation strategy.

Indexed as

Atrial FibrillationCardiac CathetersCatheter AblationPulmonary VeinsAgedEquipment DesignFemaleHumansMaleMiddle AgedProspective StudiesRecurrenceRegistriesTime FactorsTreatment OutcomeAtrial fibrillationLearning curvePulsed field ablationReal-world

Identifiers

PMID40888735
PMCPMC12400809

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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.