RecruitingNot ApplicableNCT06698159

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


Sponsor

Hospital Universitario 12 de Octubre

Enrollment

440 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specific technique for treating atrial fibrillation (an irregular heartbeat) using balloon-based freezing (cryoablation) of the pulmonary veins — the blood vessels connecting the lungs to the heart — to restore normal heart rhythm. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with atrial fibrillation (either intermittent or persistent), diagnosed within the last 2 years - Your doctor has recommended pulmonary vein isolation using balloon cryoablation **You may NOT be eligible if...** - Your left heart chamber (left atrium) is severely enlarged - You have had a previous ablation procedure for atrial fibrillation - You are severely frail or have a life expectancy less than 1 year - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECryoablation with cryoballoon 28 mm

Pulmonary vein isolation using 28 mm balloon cryoablation

DEVICECryoablation 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

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NCT06698159


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