Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-28 @ 6:19 PM
Study NCT ID:
NCT00606567
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2008-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Medusa SAK
Brief Summary:
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:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 8774 | OTHER | Duke legacy protocol number | View |