Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Pulsed Field Ablation, Irreversible Electroporation
Brief 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).
Interventions
Ablation and atrial mapping with the Globe Pulsed Field System
Sponsors
Kardium Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, Czechia, Germany, United States
Outcome results
None listed