Testing two balloon sizes for ablation treating atrial fibrillation
Compares two sizes of cryoballoon ablation in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
Key facts
- Where
- Acerra, Brescia, Latina, Maddaloni, Monza, Naples, Padova, Pozzilli, and Rome, ItalySee the 10 sites
Where in Italy
- Casa di cura Villa dei FioriAcerra, ItalyNot yet recruiting
- Poliambulanza Institute Hospital FoundationBrescia, ItalyNot yet recruiting
- Ospedale Santa Maria GorettiLatina, ItalyNot yet recruiting
- Clinica San MicheleMaddaloni, ItalyNot yet recruiting
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyNot yet recruiting
- Pellegrini HospitalNaples, ItalyNot yet recruiting
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of PadovaPadova, ItalyNot yet recruiting
- IRCCS Neuromed Mediterranean Neurological InstitutePozzilli, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"Rome, ItalyNot yet recruiting
- S. Pietro Fatebenefratelli HospitalRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario 12 de Octubre
- Trial code
- NCT06698159
- Record updated
- 20 November 2024
- Original description
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.Read full original descriptionShow less
Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI 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.
Inclusion: 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: Previous endocardial or surgical ablation of atrial fibrillation; Severe mitral or aortic valve disease; Congenital heart disease; Severe left atrial dilatation (indexed volume >48 ml/m2 or area >40 cm2 or indexed diameter >3.0 cm/m2); 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; Pregnancy or the prospect of pregnancy in the next 12 months.