Actively Recruiting
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
Led by Hospital Universitario 12 de Octubre · Updated on 2024-11-20
440
Participants Needed
17
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 17 locations
1
IRCCS Neuromed Mediterranean Neurological Institute
Pozzilli, Isernia, Italy
Not Yet Recruiting
2
Casa di cura Villa dei Fiori
Acerra, Napoli, Italy
Not Yet Recruiting
3
Poliambulanza Institute Hospital Foundation
Brescia, Italy
Not Yet Recruiting
4
Ospedale Santa Maria Goretti
Latina, Italy
Not Yet Recruiting
5
Clinica San Michele
Maddaloni, Italy
Not Yet Recruiting
6
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Not Yet Recruiting
7
Pellegrini Hospital
Naples, Italy
Not Yet Recruiting
8
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
Padova, Italy
Not Yet Recruiting
9
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
Rome, Italy
Not Yet Recruiting
10
S. Pietro Fatebenefratelli Hospital
Rome, Italy
Not Yet Recruiting
11
HU Basurto
Bilbao, Spain
Not Yet Recruiting
12
HU Virgen de las Nieves
Granada, Spain
Not Yet Recruiting
13
HU Juan Ramón Jiménez
Huelva, Spain
Not Yet Recruiting
14
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
15
HU Ramón y Cajal
Madrid, Spain
Not Yet Recruiting
16
HU Virgen de la Victoria
Málaga, Spain
Not Yet Recruiting
17
HU Virgen Macarena
Seville, Spain
Not Yet Recruiting
Research Team
D
Daniel Rodríguez Muñoz, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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