NCT02752737

Cryo Global Registry

Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,385 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry

Detailed description

The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with a commercially available Arctic Front™ Family of Cardiac Cryoablation Catheters (hereafter referred to as "Arctic Front™ Cardiac Cryoablation Catheter System"). The cryoballoon ablation(CBA) procedure will be performed according to routine hospital practice. The study is expected to have a 24 month enrollment period. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2016-05-02
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2016-04-27
• Last updated: 2025-07-30

Locations

163 sites across 38 countries: United States, Argentina, Austria, Belgium, Brunei, Chile, China, Colombia, Czechia, Germany, Greece, Hungary, Iceland, India, Indonesia, Italy, Japan, Kazakhstan, Kuwait, Malaysia, Mexico, Oman, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom