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

July 11, 2014 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life at baseline, 6 months, and 12 months. Health utilization costs incurred during the study period.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Medtronic

Investigators

  • Principal Investigator: Sana Al-Khatib, MD, MHS, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 4, 2008

Study Record Updates

Last Update Posted (Estimate)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00010068
  • 8774 (Duke legacy protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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