Evidence map›Paper›PMID 38655693›Full record

Trial reportCirculation. Arrhythmia and electrophysiology2024

Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE.

Tom De Potter, Massimo Grimaldi, Mattias Duytschaever, Ante Anic, Johan Vijgen, Petr Neuzil, Hugo Van Herendael, Atul Verma, Allan Skanes, Daniel Scherr and 5 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in Circulation. Arrhythmia and electrophysiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04524364 (Pulsed Field Ablation), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
14.1field-weighted citation impact, top 1% of its field
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.

NCT04524364 nacompletednot on this map

Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)

TypeinterventionalSponsorBiosense Webster, Inc.Ran2020 to 2023Enrolled272ConditionsAtrial FibrillationArmsPulsed Field Ablation (PFA) Therapy
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. 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 · 2025
    Trial
  3. Trial
  4. Review
  5. Irrigation-dependent acute ganglionated plexus modulation during variable-loop 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
    Observational
  6. Review
  7. Epicardial tissue heating during pulsed field ablation assessed using a novel experimental model: implications for collateral damage.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. Article
  9. 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
  10. Article
  11. 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. Article
  15. Article
  16. Article
  17. Outcomes of pulsed-field ablation with low to zero fluoroscopy utilization for atrial fibrillation treatment.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
  18. 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 · 2025
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 8 countries.

Tom De PotterOLV Hospital, Dienst Cardiologie, Aalst, Belgium (T.D.P.).ORCID 0000-0003-1424-114X
Massimo GrimaldiOspedale Generale Regionale "F. Miulli" UOC Cardiologia, Bari, Italy (M.G.).ORCID 0000-0002-9347-8884
Mattias DuytschaeverAZ Sint Jan, Brugge, Belgium (M.D.).ORCID 0000-0001-8451-0013
Ante AnicUniversity Hospital Center Split, Split, Croatia (A.A.).ORCID 0000-0002-6864-3999
Johan VijgenJessa Hospitals, Hasselt, Belgium (J.V.).ORCID 0000-0003-4928-4836
Petr NeuzilDepartment of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.N.).ORCID 0000-0003-4334-8165
Hugo Van HerendaelZiekenhuis Oost, Genk, Belgium (H.V.H.).
Atul VermaMcGill University Health Center, Montréal, Canada (A.V.).ORCID 0000-0002-1020-9727
Allan SkanesUniversity of Western Ontario, London, Canada (A.S.).ORCID 0000-0001-8332-8551
Daniel ScherrMedical University Graz, Graz, Austria (D.S.).
Helmut PürerfellnerOrdensklinikum Linz GmbH, Linz, Austria (H.P.).ORCID 0000-0002-8965-8495
Gediminas RackauskasCentre for Cardiology & Angiology, Department of Cardiovascular Diseases, Vilnius University, Lithuania (G.R.).ORCID 0000-0003-3272-4380
Pierre JaisIHU LIRYC ANR-10-IAHU-04, Centre Hospitalier Universitaire Bordeaux, Bordeaux University, Bordeaux, France (P.J.).ORCID 0000-0002-4700-7811
Vivek Y ReddyHelmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, NY; Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (V.Y.R.).ORCID 0000-0002-5638-4993
inspIRE Trial Investigators
Na Homolce Hospital · CZAZ Sint-Jan · BECentre Hospitalier Universitaire de Bordeaux · FRJessa Hospital · BEKepler Universitätsklinikum · ATMcGill University Health Centre · CAMedical University of Graz · ATOnze Lieve Vrouwziekenhuis Hospital · BEOspedale Generale Regionale Francesco Miulli · ITUniversity of Split · HRVilnius Gediminas Technical University · LTWestern University · CAZiekenhuis Oost-Limburg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success.

methodsInspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success.

resultsThe patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA

conclusionsThe inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364.

Indexed as

Atrial FibrillationCatheter AblationPulmonary VeinsAction PotentialsAgedCardiac CathetersElectrocardiography, AmbulatoryElectrophysiologic Techniques, CardiacEquipment DesignFemaleHeart RateHumansImaging, Three-DimensionalMaleMiddle AgedPredictive Value of Testsatrial fibrillationcatheterselectroporationpulmonary veins

Identifiers

PMID38655693
PMCPMC11111320
OpenAlexW4395075774

What OpenQuestion holds

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LicenceCC BY
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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.