Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
Recruiting · NCT06698159 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Universitario 12 de Octubre
View the official record on ClinicalTrials.gov →Interventions studied
Cryoablation with cryoballoon 28 mmCryoablation with cryoballoon 31 mm
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
17 locations listed.
- HU Basurto - Bilbao, Spain
- Poliambulanza Institute Hospital Foundation - Brescia, Italy
- HU Virgen de las Nieves - Granada, Spain
- HU Juan Ramón Jiménez - Huelva, Spain
- Ospedale Santa Maria Goretti - Latina, Italy
- Clinica San Michele - Maddaloni, Italy
- Hospital Universitario 12 de Octubre - Madrid, Spain
- HU Ramón y Cajal - Madrid, Spain
- Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy
- HU Virgen de la Victoria - Málaga, Spain
- 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 Virgen Macarena - Seville, Spain
- IRCCS Neuromed Mediterranean Neurological Institute - Pozzilli, Isernia, Italy
- Casa di cura Villa dei Fiori - Acerra, Napoli, Italy