UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012121
Receipt number 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 10:55:00

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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 or person

Institute

Japan Lifeline Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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