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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• A diagnosis of recurrent symptomatic paroxysmal or persistent AF
• Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Locations
Other Locations
Germany
Westpfalz-Klinikum GmbH Kaiserslautern
RECRUITING
Kaiserslautern
Contact Information
Primary
Clinical Affairs
Clinical.Affairs@kardium.com
+1 (604) 248 8891
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2028-06
Participants
Target number of participants: 115
Treatments
Experimental: Globe Pulsed Field System
Related Therapeutic Areas
Sponsors
Leads: Kardium Inc.