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

NCT07714876 — Not applicable, Not yet recruiting, 250 participants, Kardium Inc.

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A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Study

Registry	NCT07714876, acronym PULSAR PAS
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	250 (Estimated)
Sponsor	Kardium Inc. (Industry)
Conditions	Paroxysmal Atrial Fibrillation
Interventions	Globe Pulsed Field System (Device)
Dates	start 2026-12-01 (estimated), primary completion 2029-12-01 (estimated), completion 2031-12-01 (estimated), first posted 2026-07-20, last updated 2026-07-20

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Globe Pulsed Field System	Experimental	Device: Globe Pulsed Field System

Globe Pulsed Field System (Device): Ablation and atrial mapping with the Globe Pulsed Field System

+Outcome measures

Primary outcomes

12-month Treatment Success Rate [12 months]: The rate of 12-month treatment success following ablation procedure using the Globe Pulsed Field System. Treatment success is defined as freedom from treatment failure, where treatment failure includes: * Documented recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 seconds on Holter monitoring or equivalent during the effectiveness evaluation period, or by an episode documented on the entire recording of the 12-lead ECG (≥ 10 seconds) at the 12-month evaluation/visit. * Acute procedural failure * Direct current (DC) cardioversion for AF/AFL/AT during the effectiveness evaluation period * Redo ablation failure * Antiarrhythmic drugs (AADs) failure * Surgical treatment for AF/AFL/AT after the index procedure
Primary Safety Event Rate [7 days]: Rate of subjects presenting with one or more primary safety events up to and including 7 days after the index ablation procedure. Primary safety events comprise the following device- or procedure-related serious adverse events: * Death * Cardiac tamponade/perforation * Heart block * Major vascular access complication * Major bleeding * Myocardial infarction (MI) * Pericarditis requiring intervention * Pulmonary edema * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury resulting in gastroparesis * Atrio-esophageal fistula * Diaphragmatic paralysis/phrenic nerve injury * Severe pulmonary vein (PV) stenosis

+Eligibility

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

* A diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
* Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key Exclusion Criteria:

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