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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Casa di cura Villa dei Fiori
NOT_YET_RECRUITING
Acerra
Poliambulanza Institute Hospital Foundation
NOT_YET_RECRUITING
Brescia
Ospedale Santa Maria Goretti
NOT_YET_RECRUITING
Latina
Clinica San Michele
NOT_YET_RECRUITING
Maddaloni
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
Pellegrini Hospital
NOT_YET_RECRUITING
Napoli
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
NOT_YET_RECRUITING
Padua
IRCCS Neuromed Mediterranean Neurological Institute
NOT_YET_RECRUITING
Pozzilli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University Cattolica del Sacro Cuore
NOT_YET_RECRUITING
Rome
S. Pietro Fatebenefratelli Hospital
NOT_YET_RECRUITING
Rome
Spain
HU Basurto
NOT_YET_RECRUITING
Bilbao
HU Virgen de las Nieves
NOT_YET_RECRUITING
Granada
HU Juan Ramón Jiménez
NOT_YET_RECRUITING
Huelva
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
HU Ramón y Cajal
NOT_YET_RECRUITING
Madrid
HU Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
HU Virgen Macarena
NOT_YET_RECRUITING
Seville
Contact Information
Primary
Daniel Rodríguez Muñoz, MD PhD
daniel.rodriguez.mnz@gmail.com
659385591
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 440
Treatments
Active_comparator: Control strategy
Pulmonary vein isolation by 28 mm balloon cryoablation
Experimental: Experimental strategy
Pulmonary vein isolation by 31 mm balloon cryoablation
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario 12 de Octubre

This content was sourced from clinicaltrials.gov