Clinical Trial

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

Study acronym: PULSE-EU
Recruiting
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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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-12-17; most recent amendment 2026-01-28.
Status change: Not Yet Recruiting → Recruiting 2021-12-21
Trial Details
NCT Number NCT05164107
Lead Sponsor Kardium Inc.
Conditions Atrial Fibrillation
Enrollment 175 participants
Start Date 2021-12-08
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-30