Ventricular Fibrillation Clinical Trial
Official title:
A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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