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Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Sponsor: Kardium Inc.
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).
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
549
Start Date
2023-03-09
Completion Date
2026-09
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
Globe Pulsed Field System
Ablation and atrial mapping with the Globe Pulsed Field System
Locations (18)
Grandview Medical Center
Birmingham, Alabama, United States
St. Bernards Medical Center
Jonesboro, Arkansas, United States
Sutter Health - California Pacific Medical Center
San Francisco, California, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Mercy Hospital
Miami, Florida, United States
Johns Hopkins
Baltimore, Maryland, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Mt. Sinai Hospital, Guggenheim Pavilion
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
St.Paul's Hospital
Vancouver, British Columbia, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Motol and Homolka University Hospital
Prague, Czechia
Heart and Diabetes Center NRW
Bad Oeynhausen, Germany
Charité Campus Virchow Clinic
Berlin, Germany
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, Germany