PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Status: Recruiting
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
‣ Diagnosis must be confirmed within 12 months before enrollment.
⁃ (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
• Subjects between 18 and 75 years of age, inclusive
Contact Information
Primary
Clinical Affairs
Clinical.Affairs@kardium.com
+1 (604) 248 8891
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2027-05
Participants
Target number of participants: 175
Treatments
Experimental: Globe Mapping and Pulsed Field Ablation System
Authors
Nemocnice Na Homolce
Related Therapeutic Areas
Sponsors
Leads: Kardium Inc.