N/A
Completed N=176
CareLink® Network Evaluation
Source: ClinicalTrials.gov NCT01023022 ↗Enrolled (actual)
176
Serious AEs
2.8%
Results posted
Apr 2015
Primary outcomePrimary: Comparison of Remote Device Check and In-clinic Device Assessment — 40.0; 50.0; 10.0; 0.0 percentage of Investigators
Summary
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Remote Device Check and In-clinic Device Assessment |
40.0; 50.0; 10.0; 0.0; 0.0; 20 | — |
| SECONDARY Patient Ease of Use of, and Satisfaction With the Medtronic CareLink® Monitor (Including Percentage of Patients Who Prefer Follow up With Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up) |
71.8; 8.7; 18.8; 0.7; 65.1; 32.9 | — |
| SECONDARY Clinician Ease of Use of, and Satisfaction With, the Medtronic CareLink® Monitor and Website (Including Clinician General Preference, if Any, for Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up) |
— | — |
| SECONDARY Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility) |
— | — |
| SECONDARY Time and Cost Savings for Patients |
— | — |
| SECONDARY Time and Costs Savings for Physicians |
— | — |
| SECONDARY Efficiency Through Increased Flexibility and Per Procedure Time |
— | — |
| SECONDARY Handling of Unscheduled Activities (for Example, Symptoms and Events) |
25.9; 14.7; 0.9; 2.6; 1.7; 4.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have an implanted Medtronic ICD, CRT-D device that is supported by the Medtronic CareLink® Network
- Patients have to sign the Medtronic CareLink® "Statement of Privacy Principles" and the "Evaluation Data Protection Statement" documents
Exclusion Criteria
- Patients with exclusion criteria required by local law
- Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)
Data sourced from ClinicalTrials.gov (NCT01023022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.