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

January 28, 2026 updated by: Kardium Inc.

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

549

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • St.Paul's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • Czechia
      • Prague, Czechia
        • Motol and Homolka University Hospital
  • Germany
      • Bad Oeynhausen, Germany
        • Heart and Diabetes Center NRW
      • Berlin, Germany
        • Charité Campus Virchow Clinic
      • Kaiserslautern, Germany, 67655
        • Westpfalz-Klinikum GmbH Kaiserslautern
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Grandview Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernards Medical Center
    • California
      • San Francisco, California, United States, 94109
        • Sutter Health - California Pacific Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32204
        • St. Vincent's Medical Center
      • Miami, Florida, United States, 33133
        • Mercy Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital, Guggenheim Pavilion
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
12 months
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kardium Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC-189367

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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