Evidence map›Paper›PMID 40928625›Full record

Trial reportJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2026

Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation.

Kazuo Matsumoto, Kelly A van Bragt, Fred J Kueffer, Waruiru Mburu, Khaldoun G Tarakji

2 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2026. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT05120193 nacompletednot on this map

Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System

TypeinterventionalSponsorMedtronic Cardiac Ablation SolutionsRan2021 to 2024Enrolled477ConditionsAtrial FibrillationArmsMapping and Ablation
NCT05443594 nacompletednot on this map

A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation

TypeinterventionalSponsorBoston Scientific CorporationRan2023 to 2025Enrolled669ConditionsPersistent Atrial FibrillationArmsPhase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

5 authors.

Kazuo MatsumotoHigashi Matsuyama Medical Associate Hospital, Saitama, Japan. kazuom@hmahp.or.jp.ORCID http://orcid.org/0000-0001-8131-7736
Kelly A van BragtCardiac Ablation Solutions, Medtronic GmbH, Meerbusch, Germany.ORCID http://orcid.org/0000-0003-4118-4291
Fred J KuefferCardiac Ablation Solutions, Medtronic, Minneapolis, MN, USA.ORCID http://orcid.org/0009-0004-1447-8811
Waruiru MburuCardiac Ablation Solutions, Medtronic, Minneapolis, MN, USA.ORCID http://orcid.org/0000-0003-3870-9173
Khaldoun G TarakjiCardiac Ablation Solutions, Medtronic, Minneapolis, MN, USA.ORCID http://orcid.org/0000-0002-3662-2886

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCatheter ablation is beneficial in patients with symptomatic persistent atrial fibrillation (PerAF), and pulsed field ablation (PFA) is a promising energy source to safely and durably create ablation lesions. However, catheter-specific "PFA waveforms and designs" result in effectiveness and safety profiles that are not transferable to other PFA technologies. A head-to-head comparison between the dual-energy, wide-footprint lattice-tip (Sphere-9, Medtronic) and pentaspline PFA catheter (Farawave, Boston Scientific) is not yet available. Consequently, this study aims to perform an indirect treatment comparison (ITC).

methodsOutcomes (efficacy, safety, and procedure times) between the SPHERE Per-AF trial (N = 212; NCT05120193) and ADVANTAGE AF trial (N = 260; NCT05443594) studies were compared using matched-adjusted indirect comparison (MAIC) methods. Matching was performed based on subjects' baseline characteristics.

resultsAfter matching, SPHERE Per-AF showed a higher probability (OR 0.51 (95% CI:0.32 - 0.80), p = 0.003) of 12-month freedom from arrhythmias (77.4%) compared to ADVANTAGE AF (63.5%). There was no evidence of adjusted probability of a primary safety difference (OR 0.76 (95% CI:0.17 - 3.42), p = 0.72) between trials (1.8% vs. 2.3%, respectively). Adjusted procedure and pulmonary vein isolation time were comparable, but fluoroscopy time was significantly shorter in SPHERE Per-AF compared to ADVANTAGE AF (-14.4 min (95% CI:-16.2, -12.5); p < 0.01).

conclusionPFA is generally safe and efficient; however, in this ITC, SPHERE Per-AF showed a higher probability of treatment success in PerAF patients compared to ADVANTAGE AF. Overall, these results underline possible differences even amongst PFA systems, which must be validated in randomized trials. Until then, MAIC methods fill the current evidence gap. Registry and the Registration No. SPHERE Per-AF: NCT05120193 and ADVANTAGE AF: NCT05443594.

Indexed as

Atrial FibrillationCatheter AblationAgedEquipment DesignFemaleHumansMaleMiddle AgedTreatment OutcomeAtrial fibrillationCatheter ablationIndirect treatment comparisonPulsed field ablation

Identifiers

PMID40928625
PMCPMC13008996

What OpenQuestion holds

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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.