Atrial Fibrillation
Conditions
Brief 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.
Interventions
None listed
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years of age or minimum age as required by local regulations * Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter * Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Exclusion criteria
* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager * Subject with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months | 12 Months | Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System |
| Freedom from Atrial Arrhythmia at 12 Months | 12 Months | Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System. |
| Freedom from Arrythmias at 12 months | 12 Months | Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters. |
| Freedom from Device / Procedure Related Adverse Events | 12 Months | Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months. |
Countries
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, United States
Outcome results
None listed