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.
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.
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.
Parallel
Cryoablation with cryoballoon 28 mm
DevicePulmonary vein isolation using 28 mm balloon cryoablation
Cryoablation with cryoballoon 31 mm
DevicePulmonary vein isolation using 31 mm balloon cryoablation
Recurrence of atrial tachyarrhythmia
Presence of atrial fibrillation, atrial flutter, atrial tachycardia in which the atrial rate exceeds 180 beats per minute, lasting more than 30 seconds after the blanking period (8 weeks) and without pharmacological anti-arrhythmic treatment during 12 months of follow-up with continuous ECG monitoring (in patients with continuous implantable monitor) or combined (in patients without implantable monitor), by optical heart rate monitoring combined with programmed intermittent ECG and in response to detection of heart rate irregularity).
Arrhythmic load
Percentage of time the patient has atrial tachyarrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia in which the atrial rate exceeds 180 beats per minute) over the total monitored time.
Arrhythmic load
Total duration of the longest episode of atrial tachyarrhythmia for each patient (cut off point: 60 minutes)
Acute effectiveness
* Percentage of veins in which complete occlusion (grade 4) is achieved pre-application * Percentage of veins requiring change to other than randomly assigned diameter * Percentage of patients in whom time to electrical isolation is visualised * Percentage of patients in whom pulmonary vein isolation is achieved at first application * Percentage of patients with termination of AF during applications, transitioning to sinus rhythm or to atrial tachycardia or flutter
Effectiveness in follow-up
* Cardiovascular admissions * Visit to the emergency room for cardiovascular conditions * Death from any cause / death from cardiovascular cause * stroke/transient ischaemic attack * Percentage of patients requiring electrical or pharmacological cardioversion or new ablation for atrial tachyarrhythmia. * Percentage of patients with recurrence of AF after the blanking period and without pharmacological antiarrhythmic treatment. * Time to first recurrence of atrial tachyarrhythmia * Improvement in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) score from visit 0 (pre-ablation) to follow-up visit 12 months after ablation.
Safety
* Major (death, complication requiring surgical or interventional treatment (vascular, coronary, cardiac, others) or prolongation of hospital stay \>48 hours, or complication with chronic sequelae or requiring chronic treatment for its management) and minor adverse events * Intra-procedural complication rate
Acute effectiveness
* Total procedure duration * Left atrial dwell time * Radiation exposure (fluoroscopy time and dose-area product) * Time to pulmonary vein electrical isolation
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