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Clinical Trials in the USA / NCT05462145
Active, not recruiting Not applicable

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

NCT05462145 · tracked via the Priya Life Science USA tracker
Sponsor
Kardium Inc.
Phase
Not applicable
Started
2023-03-09
Last updated
2026-01-30

Condition(s) studied

Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

Globe Pulsed Field System

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)

Trial sites (18)

FacilityCityRegionStatus
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.

View NCT05462145 on ClinicalTrials.gov ↗ ← All trials in the USA