UMIN ID: UMIN000002063
Registered date:10/06/2009
Acceptance and impact evaluation on Medtronic CareLink Network
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patients with implanted cardiac pacemaker, ICD or CRT-D device. |
| Date of first enrollment | 2008/02/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 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. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Medtronic Japan Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Medtronic Japan Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 03-6430-7023 |
| Affiliation | Medtronic Japan Co., Ltd. CRDM Clinical |
| scientific contact | |
| Name | Soichi Tsunoda |
| Address | Comodio Shiodome 2-14-1 Higashi-Shimbashi Minato-ku, Tokyo Japan |
| Telephone | |
| Affiliation | Medtronic Japan Co., Ltd. CRDM Clinical |