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NCT Number: NCT05462145

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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 Persistent Atrial Fibrillation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Paul's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

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 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

Treatment and study plan

Globe Pulsed Field System

Device

Ablation and atrial mapping with the Globe Pulsed Field System

Primary outcomes

  1. Effectiveness endpoint

    Time frame: 12 months

    Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.

  2. Safety endpoint

    Time frame: 7 days

    Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.

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 or Persistent Atrial Fibrillation

Acronym: PULSAR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2022
Registry last updated
Jan 30, 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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