Evidence map›Paper›PMID 40237369›Full record

Trial reportJournal of cardiovascular electrophysiology2025

Acute Procedural Results of Pulsed Field Cryoablation for Persistent Atrial Fibrillation: Multicenter First-in-Human PARALELL Trial.

Vidal Essebag, Lucas Boersma, Jan Petru, Mark M Gallagher, Vivek Y Reddy, Tom De Potter, Pawel Derejko, Petr Neuzil, Ilya Grigorov, Atul Verma

Abstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in Journal of cardiovascular electrophysiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Feasibility and acute results of a circular over-the-wire pulse field ablation catheter for pulmonary vein isolation and linear ablation lesions.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  2. Review
  3. Review
  4. 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

10 authors.

Vidal EssebagMcGill University Health Centre, Montreal, Quebec, Canada.ORCID 0000-0003-0107-5197
Lucas BoersmaSt. Antonius Hospital, Nieuwegein, Utrecht, the Netherlands.
Jan PetruNa Homolce Hospital, Prague, Czech Republic.
Mark M GallagherSt George's University Hospitals NHS Foundation Trust, London, UK.
Vivek Y ReddyNa Homolce Hospital, Prague, Czech Republic.ORCID 0000-0002-5638-4993
Tom De PotterCardiovascular Center, OLV Hospital, Aalst, East Flanders, Belgium.
Pawel DerejkoMedicover Hospital, Warsaw, Masovian Voivodeship, Poland.ORCID 0000-0003-3317-1837
Petr NeuzilNa Homolce Hospital, Prague, Czech Republic.
Ilya GrigorovAdagio Medical Inc., Laguna Hills, California, USA.
Atul VermaMcGill University Health Centre, Montreal, Quebec, Canada.

Funding

This study was supported by the Fonds de Recherche du Québec-Santé and Adagio Medical.
6 · The paper itself

Abstract

introductionPulsed Field Cryoablation (PFCA) is a dual-energy cardiac ablation modality consisting of short-duration ultra-low temperature cryoablation (ULTC) followed immediately by pulsed field ablation (PFA) delivered from the same catheter. It is hypothesized that PFCA may improve contact stability during PFA, while maintaining lesion depth and effectiveness of ULTC.

methodsPARALELL is a first-in-human multicenter study evaluating safety and effectiveness of a novel PFCA catheter and system in patients with persistent atrial fibrillation (PsAF) using the combination of pulmonary vein (PVI) and posterior wall (PWI) isolation.

resultsSixty-six patients were ablated at six sites. One groin hematoma and one intubation-related hospitalization were the only serious procedure- or device-related adverse events recorded in the study. Per protocol, acute effectiveness was evaluated in 46 patients, including 31 patients with post-hoc analysis of cryogenic energy per lesion. After an average of 21.1 ± 9.3 lesions per patient the rates of PVI and PWI were 95.7% (176/184) and 97.7% (42/43), respectively. The average cryogenic energy per patient was highly predictive of acute isolation success with ROC AUC = 0.944% and 100% rates of both PVI and PWI in 24 patients in the optimal energy cohort. Grade I microbubbles and faint muscle contractions were detected in 1.1% and 0.5% of ablations, respectively.

conclusionThis initial multi-center experience suggests that PFCA can be efficiently performed for PVI and PWI using a single versatile catheter system, with high acute success and good early safety profile. The evaluation of the chronic 12-month effectiveness of PFCA is ongoing.

Indexed as

Atrial FibrillationCryosurgeryPulmonary VeinsAction PotentialsAgedCardiac CathetersEquipment DesignFemaleHeart RateHumansMaleMiddle AgedRisk FactorsTime FactorsTreatment Outcomecardiac mapping–3‐dimensional systemscatheter ablation—atrial fibrillationcatheter ablation—non‐RF energy sourcescryoablationelectrophysiology—atrial arrhythmiasepidemiology/clinical trialspulsed field ablation

Identifiers

PMID40237369
PMCPMC12160680

What OpenQuestion holds

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Registered trials

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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.