UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000026140