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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027654
Receipt No. R000031580
Scientific Title Micra Transcatheter Pacing System Post-Approval Registry
Date of disclosure of the study information 2017/06/06
Last modified on 2018/06/06

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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
Middle name
Last name Nicky Zuniga
Organization Medtonic, Inc.
Division name Clinical Affairs
Zip code
Address 710 Medtronic Parkway Fridley, MN 55432
TEL 1-763-526-2683
Email nicky.m.zuniga@medtronic.com

Public contact
Name of contact person
1st name
Middle name
Last name Chie Okai
Organization Medtronic Japan Co., Ltd.
Division name Clinical Affairs
Zip code
Address 1-2-70 Konan, Minato-ku,Tokyo, 108-0075, Japan
TEL 03-6776-0055
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 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
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
Anticipated trial start date
2017 Year 09 Month 01 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
2017 Year 06 Month 06 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031580

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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