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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
2026-10-06

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 or AAD naïve subjects 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 * Right atrial minor-axis (transverse) diameter \<32mm for adjunctive cavotricuspid isthmus (CTI) ablation only

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 (17)

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
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

More Kardium Inc. trials in the USA

Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation Recruiting

Other trials for the same condition

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation Recruiting
Endocardial Mapping With the CoreMap EP Mapping System Recruiting
Medtronic Terminate AF Study Recruiting
Treatment of PAF With the Synaptic System Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System Active, not recruiting
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