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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Globe Pulsed Field System

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Affairs; Phone Number: +1 (604) 248 8891; Email: Clinical.Affairs@kardium.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Globe Pulsed Field System	Device: Globe Pulsed Field System; Ablation and atrial mapping with the Globe Pulsed Field System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month Treatment Success Rate	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	12 months
Primary Safety Event Rate	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	7 days

Collaborators and Investigators

• Sponsor: Kardium Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: DOC-323676

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No