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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00606567
First received: January 22, 2008
Last updated: July 11, 2014
Last verified: December 2012
  Purpose

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
Other: Methods for monitoring patients with ICD's

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life at baseline, 6 months, and 12 months. Health utilization costs incurred during the study period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: December 2006
Study Completion Date: May 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606567

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Medtronic
Investigators
Principal Investigator: Sana Al-Khatib, MD, MHS Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00606567     History of Changes
Other Study ID Numbers: Pro00010068, 8774
Study First Received: January 22, 2008
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Defibrillators, Implantable

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014