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