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

Paroxysmal Atrial Fibrillation Clinical Trial

— PULSAR  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462145
• Other study ID #: DOC-189367
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: Kardium Inc.
• Contact: Clinical Affairs
• Phone: +1 (604) 248 8891
• Email: Clinical.Affairs[@]kardium.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 449
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Globe Pulsed Field System
Ablation and atrial mapping with the Globe Pulsed Field System

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec
Canada	St.Paul's Hospital	Vancouver	British Columbia
Czechia	Nemocnice Na Homolce	Praha
Germany	Heart and Diabetes Center NRW	Bad Oeynhausen
Germany	Charité Campus Virchow Clinic	Berlin
Germany	Westpfalz-Klinikum GmbH Kaiserslautern	Kaiserslautern
United States	Johns Hopkins	Baltimore	Maryland
United States	Grandview Medical Center	Birmingham	Alabama
United States	University of Alabama Heersink School of Medicine	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	Mercy Hospital	Miami	Florida
United States	Mt. Sinai Hospital, Guggenheim Pavilion	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Sutter Health - California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Kardium Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness endpoint	Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.	12 months
Primary	Safety endpoint	Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.	7 days