NCT06698159

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

Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Hospital Universitario 12 de Octubre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ablation has become a first-line therapy in the rhythm control strategy for atrial fibrillation (AF). Pulmonary vein electrical isolation (PVI) is the cornerstone of ablation therapy, based on its efficacy profile, safety and lack of alternatives. Single shot techniques have been increasingly used as the initial approach for PVI, employing cryoablation, i.e. release of cryoenergy into the endocardium via an inflatable catheter, to achieve isolation. The most commonly used diameter in cryoablation is 28 mm. These generate antral isolation whose profile depends on the distance between veins. When the application is made with larger devices, as has been observed with the cryoballoon with an expandable diameter of 31 mm or ablation devices using pulsed electric fields, the isolation is also antral at the level of the carina, making the result of PVI more similar to that obtained when ablation is performed with a Wide Antral Circumferential Ablation (WACA) strategy using point-to-point radiofrequency (the gold standard for PVI). The WIDER-PVI study aims to answer the question of whether single-shot ablation with a 31 mm diameter device is superior to conventional ablation with a 28 mm diameter device. The answer to this question is relevant in the context of the development of new, larger devices and concerns about the impact of larger ablation on atrial function.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation (Paroxysmal)

Interventions

Type	Name	Description
DEVICE	Cryoablation with cryoballoon 28 mm	Pulmonary vein isolation using 28 mm balloon cryoablation
DEVICE	Cryoablation with cryoballoon 31 mm	Pulmonary vein isolation using 31 mm balloon cryoablation

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-05-01
• Completion: 2027-06-30
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

17 sites across 2 countries: Italy, Spain