A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic (Medusa SAK)

Duke University

Status: Completed

Conditions: Ventricular Fibrillation; Tachycardia, Ventricular

Treatments: Other: Methods for monitoring patients with ICD's

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00606567

8774 (Other Identifier)

Pro00010068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

1-treatment

Active Comparator group

Description:

remote monitoring with carelink every 3 months

Treatment:

Other: Methods for monitoring patients with ICD's

2- control

No Intervention group

Description:

device interrogations in clinic every 3 months