UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036131 |
|---|---|
| Receipt number | R000041164 |
| Scientific Title | Micra Acute Performance Japan Regional Cohort |
| Date of disclosure of the study information | 2019/03/08 |
| Last modified on | 2023/08/29 12:35:33 |
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Basic information
Public title
Micra Acute Performance Japan Regional Cohort
Acronym
MAP Japan Regional Cohort
Scientific Title
Micra Acute Performance Japan Regional Cohort
Scientific Title:Acronym
MAP Japan Regional Cohort
Region
| Japan |
Condition
Condition
Bradycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the Micra Acute Performance Japan Regional Cohort (MAP Japan cohort) is to establish safe and effective use of the Micra system in Japan through additional collection of clinical data specific to Japanese patients. Also, frailty conditions which are reversible clinical symptoms will be collected for Micra implanted patients in Japan to additionally assess safety and efficacy of the Micra System.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate the acute major complication rate related to the Micra system and/or Micra system implant procedure.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
2. Patient is intended to be treated with an eligible product
3. Patient within enrollment window of therapy received at the time of their initial PSR platform enrollment
Key exclusion criteria
1. Patient who is, or is expected to be inaccessible for follow-up
2. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Okai |
Organization
Medtronic Japan Co.,Ltd.
Division name
Japan Clinical and Medical Affairs
Zip code
108-0075
Address
Shinagawa Season Terrace 22F, 1-2-70 Konan, Minato-ku,Tokyo
TEL
03-6776-0056
chie.okai@medtronic.com
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Okai |
Organization
Medtronic Japan Co.,Ltd.
Division name
Japan Clinical and Medical Affairs
Zip code
108-0075
Address
Shinagawa Season Terrace 22F, 1-2-70 Konan, Minato-ku,Tokyo
TEL
03-6776-0056
Homepage URL
chie.okai@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd
Institute
Department
Personal name
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-23-0269/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-23-0269/_article
Number of participants that the trial has enrolled
305
Results
A total of 11 acute major complication adverse events (onset within 30 days of implant, inclusive) were reported in 10 of the 300 patients that underwent a Micra implant attempt for an overall rate of 3.33% (95% CI: 1.61% - 6.04%).
Results date posted
| 2023 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See below
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-23-0269/_article
Participant flow
See below
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-23-0269/_article
Adverse events
See below
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-23-0269/_article
Outcome measures
See below
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-23-0269/_article
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2019 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041164
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| Registered date | File name |
| Research case data | |
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