Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry.

ABSTRACT:

Aims

Clinical studies with protocol-mandated workflow and monitoring have analysed performance of pulsed field ablation (PFA) for treating atrial fibrillation (AF). The FARADISE registry captures global use of the pentaspline PFA catheter in real-world clinical practice with a follow-up of 3 years.

Methods and results

FARADISE is a prospective, non-randomized, multi-national registry (NCT05501873) that enrolled subjects clinically indicated for ablation using the pentaspline PFA catheter per medical judgement and hospital standard-of-care. Procedural characteristics, safety, and clinical effectiveness up to 12-months were collected. In total, 1158 AF patients received PFA across 48 centres in 21 countries (64 ± 11 years, 33% female, 90% de novo, 65% paroxysmal AF). Pulmonary

SUBMITTER: Boersma LVA 

PROVIDER: S-EPMC12400809 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature