Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation (PULSAR)

Kardium

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Device: Globe Pulsed Field System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05462145

DOC-189367

Details and patient eligibility

About

This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).

Enrollment: 549 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)

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549 participants in 1 patient group

Globe Pulsed Field System

Experimental group

Treatment:

Device: Globe Pulsed Field System