Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
NCT05462145 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 549
Last updated 2026-01-30
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).
Conditions
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
Interventions
- DEVICE
-
Globe Pulsed Field System
Ablation and atrial mapping with the Globe Pulsed Field System
Sponsors & Collaborators
-
Kardium Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-09
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
- FDA Device
- Yes
Countries
- United States
- Canada
- Czechia
- Germany
Study Locations
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