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

* 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

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 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


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

Value
https://center6.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