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RECRUITING
NCT06973031
NA
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.
View on ClinicalTrials.gov
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
115
Start Date
2025-06-10
Completion Date
2028-06
Last Updated
2025-06-16
Healthy Volunteers
No
Interventions
DEVICE
Globe Pulsed Field System
Ablation and atrial mapping with the Globe Pulsed Field System
Locations (1)
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, Germany