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NCT07714876
Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation
Conditions: Paroxysmal Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 250
Sponsor: Kardium Inc.
Summary
This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.
Eligibility Criteria
Key Inclusion Criteria:
* A diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
* Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Key Exclusion Criteria:
* Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is 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 any pulmonary vein stents
* Body mass index (BMI) \>40 kg/m\^2
* Left ventricular ejection fraction (LVEF) \55mm
Source: ClinicalTrials.gov (NCT07714876). StuddyBuddy aggregates publicly available trial information.