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RECRUITING
NCT06698159
NA

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

Sponsor: Hospital Universitario 12 de Octubre

View on ClinicalTrials.gov

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

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