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Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
Sponsor: Hospital Universitario 12 de Octubre
Summary
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.
Official title: Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2024-11-01
Completion Date
2027-06-30
Last Updated
2024-11-20
Healthy Volunteers
No
Interventions
Cryoablation with cryoballoon 28 mm
Pulmonary vein isolation using 28 mm balloon cryoablation
Cryoablation with cryoballoon 31 mm
Pulmonary vein isolation using 31 mm balloon cryoablation
Locations (17)
IRCCS Neuromed Mediterranean Neurological Institute
Pozzilli, Isernia, Italy
Casa di cura Villa dei Fiori
Acerra, Napoli, 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
Rome, Italy
S. Pietro Fatebenefratelli Hospital
Rome, Italy
HU Basurto
Bilbao, Spain
HU Virgen de las Nieves
Granada, Spain
HU Juan Ramón Jiménez
Huelva, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
HU Ramón y Cajal
Madrid, Spain
HU Virgen de la Victoria
Málaga, Spain
HU Virgen Macarena
Seville, Spain