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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002063
Receipt No. R000001231
Scientific Title Acceptance and impact evaluation on Medtronic CareLink Network
Date of disclosure of the study information 2009/06/10
Last modified on 2009/06/10

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Basic information
Public title Acceptance and impact evaluation on Medtronic CareLink Network
Acronym CareLink Pilot Study
Scientific Title Acceptance and impact evaluation on Medtronic CareLink Network
Scientific Title:Acronym CareLink Pilot Study
Region
Japan

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

Objectives
Narrative objectives1 To verify that the Medtronic CareLink Network, consisting of the Medtronic CareLink Monitor Model 2490 and Medtronic CareLink Device Data Management Application Software Model 2491, can be used effectively and with high physician and subject satisfaction in a Japanese geography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Assess subject ease of use, satisfaction and acceptance of the Monitor and clinician ease of use, satisfaction and acceptance of the Website
2. To assess the impact of remote device monitoring on time and burden for subjects, clinicians, and the clinic.
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) Patient has a previously implanted device that is supported by the Medtronic CareLink Network. See
2) Patient has access to an analog telephone line that can be direct dialed to reach an outside line.
3) Patient or the patient's caregiver is willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant perform those duties.
4) Patient has signed a Patient Informed Consent form for this study.
Key exclusion criteria 1) Patient has medical conditions that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available).
2) Patient does not have a landline telephone that can be direct dialed to reach an outside line where they reside.
3) Patient is less than 20 years of age.
4) Patient has medical conditions that preclude the testing required by the protocol.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Tsunoda
Organization Medtronic Japan Co., Ltd.
Division name CRDM Clinical
Zip code
Address Comodio Shiodome 2-14-1 Higashi-Shimbashi Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Medtronic Japan Co., Ltd.
Division name CRDM Clinical
Zip code
Address
TEL 03-6430-7023
Homepage URL
Email

Sponsor
Institute Medtronic Japan Co., Ltd.
Institute
Department

Funding Source
Organization Medtronic Japan 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
2009 Year 06 Month 10 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 Completed
Date of protocol fixation
2007 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 05 Month 01 Day

Other
Other related information Subjects were requested to complete questionnaire at each study visit.
Clinic staff were requested to respond to a questionnaire at each study visit.

Time required to conduct in-clinic device follow-up as well as sending and reviewing transmitted data were also measured.

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2009 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001231

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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