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

Summary

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

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.

Conditions3

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