UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027654 |
|---|---|
| Receipt number | R000031580 |
| Scientific Title | Micra Transcatheter Pacing System Post-Approval Registry |
| Date of disclosure of the study information | 2017/06/06 |
| Last modified on | 2025/08/25 10:02:12 |
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Basic information
Public title
Micra Transcatheter Pacing System Post-Approval Registry
Acronym
Micra Transcatheter Pacing System Post-Approval Registry
Scientific Title
Micra Transcatheter Pacing System Post-Approval Registry
Scientific Title:Acronym
Micra Transcatheter Pacing System Post-Approval Registry
Region
| Japan | North America | Australia |
| Europe |
Condition
Condition
Bradycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate acute complication rate related to the Micra system and/or procedure.
To estimate the 9-year Micra related complication free survival probability.
Key secondary outcomes
To characterize treatment and/or procedure related to Micra TPS End of Device Service (EDS).
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 has or is intended to receive or be treated with an eligible product
3. Patient within enrollment window of therapy received at the time of their initial PSR platform enrollment, or meets criteria for retrospective enrollment
Key exclusion criteria
1. Patient who is, or is expected to be inaccessible for follow-up
2. Patient with exclusion criteria required by local law
3. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Target sample size
1830
Research contact person
Name of lead principal investigator
| 1st name | Amy |
| Middle name | |
| Last name | Roys |
Organization
Medtonic, Inc.
Division name
PACS
Zip code
55432
Address
710 Medtronic Parkway Fridley, MN 55432
TEL
1-501-454-7424
amy.k.roys@medtronic.com
Public contact
Name of contact person
| 1st name | Eiichiro |
| Middle name | |
| Last name | Goto |
Organization
Medtronic Japan Co., Ltd.
Division name
Clinical Research and Medical Science
Zip code
108-0075
Address
1-2-70 Konan, Minato-ku,Tokyo, 108-0075, Japan
TEL
080-4441-9938
Homepage URL
goto.eiichiro@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
YES
Study ID_1
NCT02536118
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
| 2017 | Year | 06 | Month | 06 | 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
2167
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
| 2017 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031580
