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

March 5, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

449

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 Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • Recruiting
        • St.Paul's Hospital
        • Principal Investigator:
          • St.Paul's Hospital 1033 Davie Street, BC, V6E 1M7, Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Principal Investigator:
          • McGill University Health Centre 1001 Decarie Boulevard, QC, H4A 3J1 Canada
  • Czechia
      • Praha, Czechia
        • Recruiting
        • Nemocnice Na Homolce
        • Principal Investigator:
          • Nemocnice Na Homolce Roentgenova 37/2, 150 30 Praha 5 - Motol, Czech Republic
  • Germany
      • Bad Oeynhausen, Germany
        • Recruiting
        • Heart and Diabetes Center NRW
        • Principal Investigator:
          • Heart and Diabetes Center NRW Georgstraße 11, 32545 Bad Oeynhausen, Germany
      • Berlin, Germany
        • Not yet recruiting
        • Charité Campus Virchow Clinic
        • Principal Investigator:
          • Charité Campus Virchow Clinic Augustenburger Pl. 1, 13353 Berlin, Germany
      • Kaiserslautern, Germany, 67655
        • Recruiting
        • Westpfalz-Klinikum GmbH Kaiserslautern
        • Principal Investigator:
          • Westpfalz-Klinikum GmbH Kaiserslautern Hellmut-Hartert-Straße 1, Kaiserslautern, 67655, Germany
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama Heersink School of Medicine
        • Principal Investigator:
          • University of Alabama Heersink School of Medicine 625 19th Street South, AL, 35233, USA
      • Birmingham, Alabama, United States, 35243
        • Not yet recruiting
        • Grandview Medical Center
        • Principal Investigator:
          • Grandview Medical Center 3690 Grandview Parkway, AL, 35243, USA
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • St. Bernards Medical Center
        • Principal Investigator:
          • St. Bernards Medical Center 201 East Oak Avenue, AR 72401, USA
    • California
      • San Francisco, California, United States, 94109
        • Recruiting
        • Sutter Health - California Pacific Medical Center
        • Principal Investigator:
          • Sutter Health CPMC 1101 Van Ness Ave, CA, 94109, USA
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • St. Vincent's Medical Center
        • Principal Investigator:
          • St. Vincent's Medical Center 1 Shircliff Way, FL 32204, USA
      • Miami, Florida, United States, 33133
        • Not yet recruiting
        • Mercy Hospital
        • Principal Investigator:
          • Mercy Hospital 3663 S. Miami Ave, FL, 33133, USA
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Principal Investigator:
          • Johns Hopkins 1800 Orleans Street, MD 21287, USA
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Massachusetts General Hospital 55 Fruit Street, MA 02114, USA
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Hospital
        • Principal Investigator:
          • Beaumont Hospital 3601 West 13 Mile Road, MI 48073, USA
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mt. Sinai Hospital, Guggenheim Pavilion
        • Principal Investigator:
          • Mt. Sinai Hospital 1190 Fifth Avenue - 1 South, NY 10029, USA
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Cleveland Clinic 9500 Eucid Ave, OH, 44195, USA
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Not yet recruiting
        • Doylestown Hospital
        • Principal Investigator:
          • Doylestown Hospital 595 West State Street, PA, 18901, USA
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Principal Investigator:
          • Hospital of the University of Pennsylvania 1 Convention Ave, PA, 19104, USA

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.

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)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

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)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

August 1, 2023

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.

Clinical Trials on Paroxysmal Atrial Fibrillation

Clinical Trials on Globe Pulsed Field System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe