Wide-Antral pulmonary vein isolation in patients undergoing atrial fibrillation ablation with a Single-Shot technique: rationale and design of the WIDER-PVI trial.

backgroundWide antral circumferential ablation (WACA) is considered the gold standard for pulmonary vein isolation (PVI) in atrial fibrillation (AF) ablation. Single shot devices of increasing diameter, delivering both thermal and pulsed field ablation, are being introduced in clinical practice. However, benefit of ablating larger antral areas on long-term efficacy remains unclear.

objectiveOur trial aims to determine whether ablation of a larger antral area with a larger single-shot ablation device improves rhythm outcomes compared to traditional single-shot PVI.

methodsWIDER-PVI is a prospective, multicenter, randomized controlled trial enrolling patients with paroxysmal AF of any duration or persistent AF diagnosed within the two years prior to ablation. Participants are randomized 1:1 to undergo PVI using either a single-shot device with standard (28-mm cryoballoon, control group) or larger (31-mm cryoballoon, experimental group) antral coverage. The dual primary endpoints are [1] freedom from atrial tachyarrhythmia recurrence lasting >30 s at 12 months, and [2] atrial arrhythmia burden, both assessed via wearable or implantable rhythm monitoring systems. Secondary endpoints include acute procedural metrics (procedure duration, left atrial dwell time, fluoroscopy exposure), need for balloon size crossover, recurrence patterns, repeat ablation rates, and cardiovascular events during follow-up. This study has been registered at ClinicalTrials.gov (NCT06698159).

conclusionWIDER-PVI is the first randomized trial to evaluate whether a larger-diameter single-shot device with enhanced antral coverage improves rhythm outcomes compared to standard single-shot PVI. Its findings may guide future ablation strategies, device design, and clinical decision-making in AF treatment.