A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic (Medusa SAK)
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|ClinicalTrials.gov Identifier: NCT00606567|
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : July 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tachycardia, Ventricular Ventricular Fibrillation||Other: Methods for monitoring patients with ICD's||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||May 2010|
U.S. FDA Resources
Active Comparator: 1-treatment
remote monitoring with carelink every 3 months
Other: Methods for monitoring patients with ICD's
Intervention comparing 2 different methods of monitoring patients with ICDs; at home monitoring vs. quarterly monitoring in the clinic.
No Intervention: 2- control
device interrogations in clinic every 3 months
- 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. [ Time Frame: 12 months ]
- Health-related quality of life at baseline, 6 months, and 12 months. Health utilization costs incurred during the study period. [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606567
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Sana Al-Khatib, MD, MHS||Duke University|