A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic
Medusa SAK
2 other identifiers
interventional
151
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
February 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 14, 2014
December 1, 2012
2 years
January 22, 2008
July 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Health-related quality of life at baseline, 6 months, and 12 months. Health utilization costs incurred during the study period.
12 months
Study Arms (2)
1-treatment
ACTIVE COMPARATORremote monitoring with carelink every 3 months
2- control
NO INTERVENTIONdevice interrogations in clinic every 3 months
Interventions
Intervention comparing 2 different methods of monitoring patients with ICDs; at home monitoring vs. quarterly monitoring in the clinic.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- years of age or younger
- No telephone with land line
- Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Medtroniccollaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
Al-Khatib SM, Piccini JP, Knight D, Stewart M, Clapp-Channing N, Sanders GD. Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial. J Cardiovasc Electrophysiol. 2010 May;21(5):545-50. doi: 10.1111/j.1540-8167.2009.01659.x. Epub 2009 Dec 15.
PMID: 20021522RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sana Al-Khatib, MD, MHS
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2008
First Posted
February 4, 2008
Study Start
December 1, 2006
Primary Completion
December 1, 2008
Study Completion
May 1, 2010
Last Updated
July 14, 2014
Record last verified: 2012-12