Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

NARecruitingINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

December 8, 2021

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Atrial Fibrillation
Interventions
DEVICE

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.

Trial Locations (1)

150 30

RECRUITING

Nemocnice Na Homolce, Prague

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kardium Inc.

INDUSTRY