Unique ID issued by UMIN | UMIN000025280 |
---|---|
Receipt number | R000028957 |
Scientific Title | Cryo AF Global Registry |
Date of disclosure of the study information | 2016/12/15 |
Last modified on | 2023/12/20 09:06:10 |
Cryo AF Global Registry
Cryo AF Global Registry
Cryo AF Global Registry
Cryo AF Global Registry
Japan | Asia(except Japan) | South America |
Europe |
Drug refractory and reoccurrence symptomatic paroxysmal and persistent atrial fibrillation
Cardiology |
Others
NO
Study objectives are defined to estimate cryoballoon efficacy and safety, characterize the cryoballoon ablation, report on changes in subject QoL, and describe global standard of care for AF ablation patients receiving a CBA.
Safety,Efficacy
1.Twelve-month freedom from atrial fibrillation (AF) recurrence
2.Twelve-month freedom from AF / Atrial Flutter (AFL)/Atrial Tachycardia (AT) recurrence
3.Device or procedure related adverse events for cryoablation through 12 months
Observational
18 | years-old | <= |
Not applicable |
Male and Female
Subject is over 18 years old of age
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) ot authorization per institution and geographical requirements
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
4500
1st name | Lauren |
Middle name | |
Last name | Hemingway |
Medtronic, Inc.
AFS Clinical
55112
8200 Coral Sea St. NE, MS:MVS46 | Mounds View, MN, 55112
1-763-526-0668
lauren.hemingway@medtronic.com
1st name | Takashi |
Middle name | |
Last name | Hamajima |
Medtronic Japan Co., Ltd.
Clinical and Medical Affairs OU Clinical Division 4
108-0075
1-2-70 Konan, Minato-ku,Tokyo, 108-0075, Japan
070-1356-0767
takashi.hamajima@medtronic.com
Medtronic Japan Co., Ltd.
Medtronic Japan Co., Ltd.
Profit organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
YES
NCT02752737
ClinicalTrials.gov
2016 | Year | 12 | Month | 15 | Day |
Unpublished
1254
Completed
2015 | Year | 12 | Month | 09 | Day |
2017 | Year | 02 | Month | 16 | Day |
2017 | Year | 02 | Month | 17 | Day |
2023 | Year | 06 | Month | 30 | Day |
2023 | Year | 09 | Month | 06 | Day |
2023 | Year | 09 | Month | 06 | Day |
NA
2016 | Year | 12 | Month | 15 | Day |
2023 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028957
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |