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RECRUITINGINTERVENTIONAL

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

Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form. - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Cryoablation with cryoballoon 28 mm

Pulmonary vein isolation using 28 mm balloon cryoablation

DEVICE

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