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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025280
Receipt No. R000028957
Scientific Title Cryo AF Global Registry
Date of disclosure of the study information 2016/12/15
Last modified on 2019/03/18

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Basic information
Public title Cryo AF Global Registry
Acronym Cryo AF Global Registry
Scientific Title Cryo AF Global Registry
Scientific Title:Acronym Cryo AF Global Registry
Region
Japan Asia(except Japan) South America
Europe

Condition
Condition Drug refractory and reoccurrence symptomatic paroxysmal atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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


Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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

Key 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
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Lauren
Middle name
Last name Hemingway
Organization Medtronic, Inc.
Division name AFS Clinical
Zip code 55112
Address 8200 Coral Sea St. NE, MS:MVS46 | Mounds View, MN, 55112
TEL 1-763-526-0668
Email lauren.hemingway@medtronic.com

Public contact
Name of contact person
1st name Chie
Middle name
Last name Okai
Organization Medtronic Japan Co., Ltd.
Division name Cardiovascular Group
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku,Tokyo, 108-0075, Japan
TEL 03-6776-0056
Homepage URL
Email chie.okai@medtronic.com

Sponsor
Institute Medtronic Japan Co., Ltd.
Institute
Department

Funding Source
Organization Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saiseikai Kumamoto Hospital
Address 5-3-1 Chikami Minami-ku Kumamoto city, Kumamoto 861-4193, Japan
Tel 096-351-8000
Email rks@saiseikaikumamoto.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02752737
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2016 Year 12 Month 15 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.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


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