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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

NCT05164107 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-01-30

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • Kardium Inc.

    lead INDUSTRY

Principal Investigators

  • Motol and Homolka University Hospital · V Úvalu 84/1, 150 00 Prague 5, Czech Republic

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164107 on ClinicalTrials.gov