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
Globe Pulsed Field System: Ablation and atrial mapping with the Globe Pulsed Field System
Study summary
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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Effectiveness endpoint — 12 months Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Safety endpoint — 7 days Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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