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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cryoablation with cryoballoon 28 mm: Pulmonary vein isolation using 28 mm balloon cryoablation

Cryoablation with cryoballoon 31 mm: Pulmonary vein isolation using 31 mm balloon cryoablation

Study 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

Primary outcome measure(s)

• Recurrence of atrial tachyarrhythmia — From enrollment to the end of follow up, assessed up to 12 months
  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 — From enrollment to the end of follow up, assessed up to 12 months
  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 — From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient
  Total duration of the longest episode of atrial tachyarrhythmia for each patient (cut off point: 60 minutes)

Trial sites (17)

More Hospital Universitario 12 de Octubre trials in Spain

Other trials for the same condition