Medtronic CareLink® Network Evaluation Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 176
- Locations
- 10
- Primary Endpoint
- Comparison of Remote Device Check and In-clinic Device Assessment
Study Overview
Brief 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.
Detailed Description
Evaluation's objectives:
Comparison of remote device check and in-clinic device assessment. To assess patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor To assess clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website To assess the clinic specific clinical value of Medtronic CareLink® Network Demonstrate time savings for patients Demonstrate time savings for physicians To show the increase of efficiency through increased flexibility and per procedure time To demonstrate better handling of unscheduled activities (symptoms, events, etc.)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Comparison of Remote Device Check and In-clinic Device Assessment
Time Frame: Baseline to max. 12 months
"Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"
Secondary Outcomes
- 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)(Baseline to max. 12 months)
- Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)(Baseline to max. 12 months)
- Time and Cost Savings for Patients(Baseline to max. 12 months)
- 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)(Baseline to max. 12 months)
- Time and Costs Savings for Physicians(Baseline to max. 12 months)
- Efficiency Through Increased Flexibility and Per Procedure Time(Baseline to max. 12 months)
- Handling of Unscheduled Activities (for Example, Symptoms and Events)(Baseline to max. 12 months)