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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Duke University
Medtronic
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00606567
  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
Device: carelink monitoring system

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Pacemakers and Implantable Defibrillators   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic

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
Estimated Study Completion Date:   February 2009
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1-treatment: Active Comparator
remote monitoring with carelink every 3 months
Device: carelink monitoring system
remote monitoring with carelink every 3 months
2- control: No Intervention
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

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


Responsible Party:   Duke University Medical Center ( Sana Al-Khatib, MD )
Study ID Numbers:   00010068 / 8774, Not applicable to our study
First Received:   January 22, 2008
Last Updated:   August 15, 2008
ClinicalTrials.gov Identifier:   NCT00606567
Health Authority:   United States: Institutional Review Board

Keywords provided by Duke University:
Defibrillators, Implantable  

Study placed in the following topic categories:
Heart Diseases
Tachycardia
Paroxysmal ventricular fibrillation
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 06, 2008




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