A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

ConditionsParoxysmal Atrial Fibrillation (PAF)Persistent Atrial Fibrillation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorKardium Inc.

About this trial

The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.

Eligibility criteria

Qualifiers

A diagnosis of recurrent symptomatic paroxysmal or persistent AF

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

Disqualifiers

Long-standing persistent AF (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

115 Participants

are divided into 1 treatment group

Sponsors and collaborators

Kardium Inc.

Lead sponsor

Source ClinicalTrials.gov