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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKardium Inc.

About this trial

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).

Eligibility criteria

Qualifiers

Subjects planned for an AF catheter ablation procedure, with a documented history of AF.

Diagnosis must be confirmed within 12 months before enrollment.

(Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation

Subjects between 18 and 75 years of age, inclusive

Disqualifiers

Patients who have contraindications to open heart surgery

Patients from an Intensive Care Unit

Patients with active systemic infection (sepsis)

Patients who have had previous ablation in the left or right atrium

Trial design

Treatments tested in this trial

  • Globe Mapping and Pulsed Field Ablation System (Globe PF System)

Treatment groups

175 Participants
are divided into 1 treatment group

Sponsors and collaborators