ArticleJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2022
Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study.
Article in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2022. 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 6 papers.
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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.
Cryterion Cardiac Cryoablation System CE Mark Study
Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry
Who cites it
6 citing papers in PubMed, 11 citations in OpenAlex.
- Prospective evaluation of antral lesion size of the 31-mm size of a novel size-adjustable cryoballoon: Results of the BETTER-FIT study.Heart rhythm O2 · 2025Article
- Novel vs established cryoballoon ablation system for atrial fibrillation: A systematic review and meta-analysis.Heart rhythm O2 · 2025Article
- In vivo safety and pulmonary vein isolation performance of a new cryoballoon for the treatment of atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024Article
- Treatment of atrial fibrillation with second-generation cryoballoon followed by contact-sensing radiofrequency catheter ablation for arrhythmia recurrences-results of a 5-year follow-up.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024Article
- Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation: study protocol for a multicenter randomized controlled trial (CONTRAST-CRYO Trial).Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024Article
- Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation.Frontiers in cardiovascular medicine · 2022Article
Corrections and comments
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Authors and funding
13 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecently, a novel cryoballoon ablation catheter has demonstrated acute safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (PAF). However, there are limited studies demonstrating the long-term efficacy. The aim of this study was to evaluate the long-term safety and efficacy of this novel cryoballoon in treating PAF.
methodsThis was a non-randomized, prospective, multicentre study enrolling 58 consecutive patients. Cryoablation was delivered for 180 s if time to isolation was ≤ 60 s. Otherwise a 240-s cryoablation was performed. One centre performed pre- and post-ablation high-density mapping (n = 9) to characterize lesion formation. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. All patients were followed for 1 year.
resultsAcute PVI was achieved in 230 of 231 pulmonary veins (99.6%) with 5.3 ± 1.6 cryoablations per patient (1.3 ± 0.7 cryoablations per vein). Forty-three (77%) patients remained arrhythmia-free at 1-year follow-up. Four patients (6.9%) experienced phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post-index procedure. For patients who underwent high-density mapping, cryoablation was antral with 50% of the posterior wall ablated.
conclusionsInitial multicentre clinical experience with a novel cryoballoon has demonstrated safety and efficacy of PVI in patients with PAF. Ablation with this cryoballoon provides a wide, antral lesion set with significant debulking of the posterior wall of the left atrium.
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Registered trials
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