Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario 12 de Octubre

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cryoablation with cryoballoon 28 mm
  • Cryoablation with cryoballoon 31 mm

Treatment groups

440 Participants
are divided into 2 treatment groups