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Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Sponsor: Kardium Inc.
Summary
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
Official title: PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2021-12-08
Completion Date
2027-05
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
Globe Mapping and Pulsed Field Ablation System (Globe PF System)
During the procedure, the Globe Catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe PF System will be used to confirm PVI.
Locations (1)
Motol and Homolka University Hospital
Prague, Czechia