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

Not Applicable

Completed

• Conditions: Tachycardia, Ventricular; Ventricular Fibrillation
• Interventions: Other: Methods for monitoring patients with ICD's

• Registration Number: NCT00606567
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-04
• Primary Completion: 2008-12
• Study Completion: 2010-05
• Status Verified: 2012-12
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-treatment	Methods for monitoring patients with ICD's	remote monitoring with carelink every 3 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Health-related quality of life at baseline, 6 months, and 12 months. Health utilization costs incurred during the study period.	12 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States