Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Purpose
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).
Conditions
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Globe Pulsed Field System |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Kardium Inc.