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

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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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Globe Pulsed Field System

Device

Ablation and atrial mapping with the Globe Pulsed Field System

Primary outcomes

12-month Treatment Success Rate

Time frame: 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

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Affairs

CONTACT

[email protected]

+1 (604) 248 8891

Sponsors and collaborators

Lead sponsor

Kardium Inc.

Industry

Registry information

Official study title

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

Acronym: PULSAR PAS

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2031
First posted: Jul 20, 2026
Registry last updated: Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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