RecruitingNot ApplicableNCT06973031
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Sponsor
Kardium Inc.
Enrollment
115 participants
Start Date
Jun 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria2
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF
- Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Exclusion Criteria10
- 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
Interventions
DEVICEGlobe Pulsed Field System
Ablation and atrial mapping with the Globe Pulsed Field System
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06973031
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