UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012121
Receipt No. R000014175
Scientific Title Evaluation of the usability of SMARTVIEW Remote Monitoring system
Date of disclosure of the study information 2013/10/28
Last modified on 2017/10/30

* 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 Evaluation of the usability of SMARTVIEW Remote Monitoring system
Acronym SMARTVIEW study
Scientific Title Evaluation of the usability of SMARTVIEW Remote Monitoring system
Scientific Title:Acronym SMARTVIEW study
Region
Japan

Condition
Condition Patients with implanted ICD or CRT-D device.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usability of Sorin's SMARTVIEW Remote Monitoring system by medical staff and patients.
Basic objectives2 Others
Basic objectives -Others reliability,satisfaction level
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate usability, reliability and satisfaction of Sorin SMARTVIEW Remote Monitoring system by medical staff and patients.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)ICD or CRT-D Patients with Sorin
SMARTVIEW Remote Monitoring system.
2)Patients who use a SMARTVIEW monitor
3)Patients who have a phone line which is accessible to a land line.-except a phone for Internet connection only
4)Patients signed on informed consent
Key exclusion criteria 1)Patients who do not consent
2)Patients have poor health
not suitable for study participation
3)Patients who do not have a phone line which is accessible to a land line
4)Age of less than 20 years
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenjiro Hara
Organization Japan Lifeline Co., Ltd.
Division name Arrhythmia Business Division
Zip code
Address 6F, Tennoz Central Tower, 2-2-24, Higashishinagawa, Shinagawa-ku, Tokyo 140-0002 Japan
TEL 03-6711-5263
Email m-nomura@jll.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenjiro Hara
Organization Japan Lifeline Co., Ltd.
Division name Arrhythmia Business Division
Zip code
Address 6F, Tennoz Central Tower, 2-2-24, Higashishinagawa, Shinagawa-ku, Tokyo 140-0002 Japan
TEL 03-6711-5263
Homepage URL
Email m-nomura@jll.co.jp

Sponsor
Institute Japan Lifeline Co., Ltd.
Institute
Department

Funding Source
Organization Japan Lifeline 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
2013 Year 10 Month 28 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
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 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 1)Medical staff are requested to respond to a questionnaire about SMARTVIEW system.
2)Medical staff are requested to hear patients' opinions about SMARTVIEW Monitor.

Management information
Registered date
2013 Year 10 Month 25 Day
Last modified on
2017 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014175

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.