UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002063 |
|---|---|
| Receipt number | 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 16:26:52 |
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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
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
Sponsor or person
Institute
Medtronic Japan Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001231
