Why the study?
To evaluate the safety and effectiveness of a fully integrated biphasic pulsed field ablation system with a variable-loop circular catheter for treating drug-refractory paroxysmal AF.
Does pulmonary vein isolation using a novel biphasic pulsed field ablation system safely and effectively improve freedom from atrial arrhythmia in patients with drug-refractory paroxysmal atrial fibrillation?
Population
226 subjects with drug-refractory paroxysmal AF across 13 centers in Europe/Canada
Comparison
Pulmonary vein isolation using a biphasic pulsed field ablation system
Design
Multicenter two-phase prospective study
Follow-up
12 months
Authors
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Demonstrates promising safety and effectiveness of integrated PFA for paroxysmal AF; leaves open confirmation in randomized trials before adoption.
Does pulmonary vein isolation using a novel biphasic pulsed field ablation system safely and effectively improve freedom from atrial arrhythmia in patients with drug-refractory paroxysmal atrial fibrillation?
A novel mapping-integrated biphasic pulsed field ablation system demonstrated safety and effectiveness for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
Duytschaever et al. (2023) studied this question.
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