NCT06973031RecruitingNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Kardium Inc.
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Effectiveness endpoint
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- 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
Arms & Interventions
Globe Pulsed Field System
Experimental
Intervention: Globe Pulsed Field System (Device)
Outcomes
Primary Outcomes
Effectiveness endpoint
Time Frame: 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
Time Frame: 7 days
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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