UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023158 |
|---|---|
| Receipt number | R000026140 |
| Scientific Title | Reveal LINQ Registry |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2021/07/19 16:25:45 |
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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
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
kazuhiro.hidaka@medtronic.com
Sponsor or person
Institute
Medtronic Japana Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.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 |
