Cryo AF Global Registry



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:May 2016
End Date:December 2024
Contact:Katie Flor
Email:Katie.J.Flor@medtronic.com
Phone:17635269651

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

The Cryo AF 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.

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 exclusion criteria required by local law
We found this trial at
3
sites
Urbana, Illinois 61801
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Buenos Aires,
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