A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic

Study Overview
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Brief Summary
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The purpose of this study is to determine if remote monitoring of implantable cardioverter defibrillators (ICD), compared with quarterly device interrogations in clinic, will improve patients' outcomes and satisfaction and will reduce health care costs.

Detailed Description
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Sudden cardiac death (SCD), usually due to a ventricular tachyarrhythmia, is the most common cause of death in the United States. The implantable cardioverter defibrillator (ICD) has been shown to improve the survival of patients with a history of a heart attack and a weak heart (functioning at 30% or less) and those with symptomatic congestive heart failure symptoms (hearts functioning at 35% or less). Thus, the number of patients who will require ICD therapy is expected to rise exponentially over the next several years. To facilitate the follow-up of patients with ICDs, device companies have launched systems for remote monitoring of these devices. One such system is the Medtronic Carelink Monitor. Although this system has been proven in a multicenter, prospective study to be easy to use, it is not known whether this monitor results in improved patients' outcomes and satisfaction and in reduced healthcare costs. Comparison: Patient outcomes, costs, and satisfaction will be evaluated, comparing patients assigned to follow-up using the Medtronic Carelink Monitor versus quarterly visits to an outpatient clinic.

Official Title
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A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic

Conditions
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Tachycardia, Ventricular, Ventricular Fibrillation

Intervention / Treatment
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* Other: Methods for monitoring patients with ICD's


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Must have an ICD with or without CRT for an approved indication Must be planning to have their devices followed-up at Duke Must have a telephone (land line) Willing and able to provide informed consent. Exclusion Criteria: 18 years of age or younger No telephone with land line Unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-treatment<br>remote monitoring with carelink every 3 months | Other: Methods for monitoring patients with ICD's<br>* Intervention comparing 2 different methods of monitoring patients with ICDs; at home monitoring vs. quarterly monitoring in the clinic.<br>|
| No Intervention: 2- control<br>device interrogations in clinic every 3 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-hospitalization and ED visits for cardiac causes, unscheduled clinic visits for device-related issues, medications, patient logs, patients' level of satisfaction with their device care at baseline, 6 months, and 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life at baseline, 6 months, and 12 months. Health utilization costs incurred during the study period. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Defibrillators, Implantable