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Acceptance and impact evaluation on Medtronic CareLink Network

Acceptance and impact evaluation on Medtronic CareLink Network - CareLink Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000002063
Enrollment
200
Registered
2009-06-10
Start date
2008-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with implanted cardiac pacemaker, ICD or CRT-D device.

Interventions

None listed

Sponsors

Medtronic Japan Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026