Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKardium Inc.

About this trial

This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.

Eligibility criteria

Qualifiers

A diagnosis of recurrent symptomatic paroxysmal atrial fibrillation

Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Disqualifiers

Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is sustained >12 months)

Atrial fibrillation secondary to a reversible cause or of non-cardiac origin

History of thromboembolic events within the past six months

Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months

Trial design

Treatments tested in this trial

  • Globe Pulsed Field System

Treatment groups

250 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators