Testing two balloon sizes for ablation treating atrial fibrillation
Compares two sizes of cryoballoon ablation in adults with atrial fibrillation.
Key facts
- Who runs it
- Hospital Universitario 12 de Octubre
- Where
- Acerra, Brescia, Latina, Maddaloni, Monza, Naples, Padova, Pozzilli, and Rome, ItalySee the 10 sitesAlso in 1 other country, 7 sites
- Trial code
- Registry title
- Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
- Status
- Recruiting
- People taking part
- 440 people, planned
- Started
- 1 Nov 2024
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cryoablation with cryoballoon 28 mm
- Cryoablation with cryoballoon 31 mm
- Record updated
- 20 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with paroxysmal or persistent atrial fibrillation who are planned to have a pulmonary vein isolation procedure with a cryoablation balloon.
- Age
- Over 18 years old
- Sex
- All sexes
- Disease stage
- Paroxysmal or persistent atrial fibrillation, diagnosed less than 2 years ago
- Earlier treatment
- No previous catheter or surgical ablation for atrial fibrillation
Main reasons for not taking part
- Severely enlarged left atrium
- Previous catheter or surgical ablation of atrial fibrillation
- Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy under 1 year
- Cannot take blood thinners, or cannot tolerate heparin
- Blood clot inside the atrium, severe mitral or aortic valve disease, or congenital heart disease
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 1 other country, 7 sites
- Casa di cura Villa dei FioriAcerra, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- Poliambulanza Institute Hospital FoundationBrescia, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- Ospedale Santa Maria GorettiLatina, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- Clinica San MicheleMaddaloni, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- Pellegrini HospitalNaples, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of PadovaPadova, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- IRCCS Neuromed Mediterranean Neurological InstitutePozzilli, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"Rome, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
- S. Pietro Fatebenefratelli HospitalRome, ItalyContact: Daniel Rodríguez Muñoz, MD PhDNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Control strategyExisting treatment, for comparison
Pulmonary vein isolation by 28 mm balloon cryoablation
Treatment: Cryoablation with cryoballoon 28 mm
- Experimental strategyTreatment being tested
Pulmonary vein isolation by 31 mm balloon cryoablation
Treatment: Cryoablation with cryoballoon 31 mm
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial
- Plain-language title
- Testing two balloon sizes for ablation treating atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Wide-Antral pulmonary vein isolation in patients undergoing atrial fibrillation ablation with a Single-Shot technique: rationale and design of the WIDER-PVI trial.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2026
- Record updated
- 20 November 2024