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Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)

RecruitingNAAges 18 Years - anyAllHospital Universitario 12 de Octubre
NCT06698159 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of \>30 seconds duration and in overall arrhythmic load.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age over 18 years old. * Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 years after diagnosis. * Clinical indication to undergo a pulmonary vein isolation procedure using balloon cryoablation. Exclusion Criteria: * Severe left atrial dilatation (indexed volume \>48 ml/m2 or area \>40 cm2 or indexed diameter \>3.0 cm/m2). * Previous endocardial or surgical ablation of atrial fibrillation. * Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy less than 1 year. * Inability to understand or give informed consent. * Performance of other left atrial ablations in addition to pulmonary veins. * Need to use another catheter in addition to the cryoablation catheter to complete pulmonary vein isolation. * Contraindication to anticoagulation or intolerance to heparin. * Presence of intra-atrial thrombus. * Reversible cause of atrial fibrillation. * Severe mitral or aortic valve disease. * Congenital heart disease. * Pregnancy or the prospect of pregnancy in the next 12 months.
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What it tests

  • Cryoablation with cryoballoon 28 mm
  • Cryoablation with cryoballoon 31 mm
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Where

17 sites
IRCCS Neuromed Mediterranean Neurological Institute
Pozzilli, Italy
Casa di cura Villa dei Fiori
Acerra, Italy
Poliambulanza Institute Hospital Foundation
Brescia, Italy
Ospedale Santa Maria Goretti
Latina, Italy
Clinica San Michele
Maddaloni, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Pellegrini Hospital
Naples, Italy
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
Padova, Italy

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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