Globe Pulsed Field System: Ablation and atrial mapping with the Globe Pulsed Field System
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Effectiveness endpoint — 12 months Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Safety endpoint — 7 days Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
Trial sites (18)
Facility
City
Region
Status
Grandview Medical Center
Birmingham
Alabama
St. Bernards Medical Center
Jonesboro
Arkansas
Sutter Health - California Pacific Medical Center
San Francisco
California
St. Vincent's Medical Center
Jacksonville
Florida
Mercy Hospital
Miami
Florida
Johns Hopkins
Baltimore
Maryland
Beaumont Hospital
Royal Oak
Michigan
Mt. Sinai Hospital, Guggenheim Pavilion
New York
New York
Cleveland Clinic
Cleveland
Ohio
Doylestown Hospital
Doylestown
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Pennsylvania
Texas Cardiac Arrhythmia Research Foundation
Austin
Texas
St.Paul's Hospital
Vancouver
British Columbia
McGill University Health Centre
Montreal
Quebec
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
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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