Evidence map›Paper›PMID 38760584›Full record

Trial reportNature medicine2024

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Elad Anter, Moussa Mansour, Devi G Nair, Dinesh Sharma, Tyler L Taigen, Petr Neuzil, Erich L Kiehl, Josef Kautzner, Jose Osorio, Stavros Mountantonakis and 11 more

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05120193 (Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System), which is not on this map. Cited by 84 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 4 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.

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
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. 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
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX 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
    Trial
  6. Trial
  7. Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Trial
  8. Trial
  9. Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized CEASE-AF trial†.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025
    Trial
  10. Article
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  12. Review
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24 more citing papers are in PubMed but not listed here.

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

21 authors.

Elad AnterShamir Medical Center, Be'er Ya'Akov, Israel. eladan@shamir.gov.il.
Moussa MansourMassachusetts General Hospital, Boston, MA, USA.
Devi G NairSt. Bernards Medical Center & Arrhythmia Research Group, Jonesboro, AR, USA.
Dinesh SharmaNCH Rooney Heart Institute, Naples, FL, USA.
Tyler L TaigenCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-1258-8118
Petr NeuzilNa Homolce Hospital, Prague, Czechia.
Erich L KiehlSentara, Norfolk, VA, USA.
Josef KautznerIKEM Prague, Prague, Czechia.
Jose OsorioHCA Florida Miami, Miami, FL, USA.
Stavros MountantonakisNorthwell, New Hyde Park, NY, USA.
Andrea NataleTexas Cardiac Arrhythmia Institute, Austin, TX, USA.
John D HummelDivision of Cardiology, Ohio State University, Columbus, OH, USA.
Anish K AminRiverside Methodist Hospital, Upper Arlington, OH, USA.
Usman R SiddiquiFlorida Cardiology, Orlando, FL, USA.
Doron HarlevMedtronic, Mounds View, MN, USA.
Paul HultzMedtronic, Mounds View, MN, USA.
Shufeng LiuMedtronic, Mounds View, MN, USA.
Birce OnalMedtronic, Mounds View, MN, USA.
Khaldoun G TarakjiMedtronic, Mounds View, MN, USA.ORCID 0000-0002-3662-2886
Vivek Y ReddyHelmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, NY, USA.
SPHERE PER-AF Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .

Indexed as

Atrial FibrillationCatheter AblationAgedFemaleHumansMaleMiddle AgedRecurrenceSingle-Blind MethodTreatment Outcome

Identifiers

PMID38760584
PMCPMC11333282

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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.