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Pulsed Field Ablation of Atrial Fibrillation: CENTAURI Versus FARAPULSE
Sponsor: St. Anne's University Hospital Brno, Czech Republic
Summary
The aim of this study is to compare the efficacy of two commercially available pulsed field ablation (PFA) systems for catheter ablation of atrial fibrillation. Patients are randomized 1:1 to point-by-point PFA using the CENTAURI PEF system with 3D electroanatomical mapping, or to single-shot PFA using the FARAPULSE pentaspline catheter guided by fluoroscopy and intracardiac echocardiography. The primary endpoint is freedom from documented atrial arrhythmia recurrence between 3 and 12 months after ablation.
Official title: Prospective Randomized Clinical Comparison of Catheter Ablation of Atrial Fibrillation Using the CENTAURI PEF System and the FARAPULSE System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
325
Start Date
2024-05-17
Completion Date
2026-10-05
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
CENTAURI PEF system
Point-by-point pulsed field ablation using the CENTAURI generator connected to a contact-force sensing focal ablation catheter (TactiCath SE, Abbott), guided by the EnSite Precision 3D electroanatomical mapping system (Abbott). Pulmonary vein isolation is performed in all patients; additional ablation of low-voltage areas is at the operator's discretion. Procedure performed under general anesthesia.
FARAPULSE system
Single-shot pulsed field ablation using the FARAPULSE system (Boston Scientific) with a multielectrode pentaspline ablation catheter, guided by fluoroscopy and intracardiac echocardiography without a 3D mapping system. Pulmonary vein isolation is performed in all patients; additional ablation of low-voltage or fractionated areas is at the operator's discretion. Procedure performed under general anesthesia.
Locations (1)
St. Anne's University Hospital Brno
Brno, Czechia