CareLink® Network Evaluation

Study Overview
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Brief Summary
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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
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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.)

Official Title
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Medtronic CareLink® Network Evaluation Protocol

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Medtronic CareLink® Network


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medtronic CareLink® Network<br>Patients with implanted Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System. The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website. | Other: Medtronic CareLink® Network<br>* The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Remote Device Check and In-clinic Device Assessment | 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 | Baseline to max. 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Participants were asked questions to which they could have respond multiple answers. 1) Which form of device follow up do you prefer? Answers: Monitor from home and in hospital follow up is necessary; Follow up only in hospital; No preference, and 2) How would you judge the user friendliness of the monitor in total? Answers: Very easy; Easy; Difficult; Missing Data, and 3) How did the monitor changed your daily life? did you felt more or less safe? Answers: Much more safe; Safe; No influence; Unsafe; Missing data | 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 | 
| 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 | 
| 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) | Investigators were asked to classify reasons for unscheduled visits by marking all applicable answers. Answer: 1) patient symptoms 2) adequate therapy/shock 3) appearance of already known arrythmias 4) appearance of new arrythmias 5) need for reprogramming 6) in house Follow-up 7) device alert 8) inadequate therapy/shock 9) worsening of pump function 10) malfunction of the device 11) other | Baseline to max. 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CareLink, Remote Monitoring, Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillators