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COMPLETED
NCT07902739
NA

Pulsed Field Ablation of Atrial Fibrillation: CENTAURI Versus FARAPULSE

Sponsor: St. Anne's University Hospital Brno, Czech Republic

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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