UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036131
Receipt No. R000041164
Scientific Title Micra Acute Performance Japan Regional Cohort
Date of disclosure of the study information 2019/03/08
Last modified on 2019/05/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Chie Okai
Organization Medtronic Japan Co.,Ltd.
Division name Cardiovascular Group (CVG)
Zip code
Address Shinagawa Season Terrace 22F, 1-2-70 Konan, Minato-ku,Tokyo 108-0075
TEL 03-6776-0056
Email chie.okai@medtronic.com

Public contact
Name of contact person
1st name
Middle name
Last name Chie Okai
Organization Medtronic Japan Co.,Ltd.
Division name Cardiovascular Group (CVG)
Zip code
Address Shinagawa Season Terrace 22F, 1-2-70 Konan, Minato-ku,Tokyo 108-0075
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
Address
Tel
Email

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
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 Open public recruiting
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 03 Month 31 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
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.