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 (GLOBAL-PF)

Kardium

Status: Enrolling

Conditions: Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation (PAF)

Treatments: Device: Globe Pulsed Field System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06973031

DOC-285345

Details and patient eligibility

About

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.

Enrollment: 115 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

• A diagnosis of recurrent symptomatic paroxysmal or persistent AF
• Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

• 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
• Any cardiac surgery within the previous six months
• Prior left atrial ablation or surgical procedure
• Presence of an implanted cardiac device
• Body mass index (BMI) >40 kg/m^2
• Left ventricular ejection fraction (LVEF) <35%
• Anterior-posterior left atrial (LA) diameter >55mm

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

115 participants in 1 patient group

Globe Pulsed Field System

Experimental group

Treatment:

Device: Globe Pulsed Field System