|
|
|
|
|
|
Sponsors and Collaborators: |
Duke University Medtronic |
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00606567 |
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.
Condition | Intervention |
Tachycardia, Ventricular Ventricular Fibrillation |
Device: carelink monitoring system |
Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
MedlinePlus related topics: | Pacemakers and Implantable Defibrillators |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic |
Enrollment: | 151 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1-treatment: Active Comparator
remote monitoring with carelink every 3 months
|
Device: carelink monitoring system
remote monitoring with carelink every 3 months
|
2- control: No Intervention
device interrogations in clinic every 3 months
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |||||
Duke University Medical Center | |||||
Durham, North Carolina, United States, 27710 |
Duke University |
Medtronic |
Principal Investigator: | Sana Al-Khatib, MD, MHS | Duke University |
Responsible Party: | Duke University Medical Center ( Sana Al-Khatib, MD ) |
Study ID Numbers: | 00010068 / 8774, Not applicable to our study |
First Received: | January 22, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00606567 |
Health Authority: | United States: Institutional Review Board |
|
|
|
|