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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023158
Receipt No. R000026140
Scientific Title Reveal LINQ Registry
Date of disclosure of the study information 2016/09/01
Last modified on 2021/07/19

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Basic information
Public title Reveal LINQ Registry
Acronym Reveal LINQ Registry
Scientific Title Reveal LINQ Registry
Scientific Title:Acronym Reveal LINQ Registry
Region
Japan Asia(except Japan) North America
Europe

Condition
Condition Unexplained syncope
Cryptogenic Sroke
Classification by specialty
Cardiology Neurology Neurosurgery
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the Reveal LINQ Registry is to generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information, and will assist with identification of the Reveal LINQ Insertable Cardiac Monitor (ICM) in the care pathway.
Basic objectives2 Others
Basic objectives -Others NA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Characterize clinical actions initiated by Reveal LINQ arrhythmia detection
Estimate procedure-related acute infection rate
Key secondary outcomes Characterize healthcare utilization
Characterize conditions diagnosed and clinical actions taken initiated by Reveal LINQ detection
Characterize procedure-related acute infections
Characterize onset and/or progression of diseases
Summarize reasons for post-insertion modifications to Reveal LINQ

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 Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Subject consent prior to Reveal LINQ ICM insertion

Subject is intended to have a Reveal LINQ ICM inserted in the next 30 days
Key exclusion criteria Subject who is, or is expected to be inaccessible for follow-up

Subject with exclusion criteria required by local law

Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee.
Target sample size 2300

Research contact person
Name of lead principal investigator
1st name Laura
Middle name
Last name Manotta
Organization Medtronic Core Clinical Solutions
Division name Study & Scientific Solutions
Zip code 20156
Address Via Varesina, 162, Milan, Italy
TEL +39.0224137275
Email laura.manotta@medtronic.com

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Hidaka
Organization Medtronic Japana Co., Ltd.
Division name Japan Clinical and Medical Affairs
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku,Tokyo, 108-0075, Japan
TEL 03-6774-4611
Homepage URL
Email kazuhiro.hidaka@medtronic.com

Sponsor
Institute Medtronic Japana Co., Ltd
Institute
Department

Funding Source
Organization Medtronic Japana 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 The Japanese Association for the Promotion of State-of-the-Art in Medicine, Specified Nonprofit Corporation
Address 2-24-2 Chikusa, Chikusa-ku, Nagoya, 464-0858, Japan
Tel 052-745-6881
Email info-irb@japsam.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02746471
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 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 1614
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
2016 Year 06 Month 02 Day
Date of IRB
2016 Year 05 Month 02 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2021 Year 06 Month 04 Day
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2016 Year 07 Month 13 Day
Last modified on
2021 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026140

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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