Status:
COMPLETED
Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients
Lead Sponsor:
Duke University
Collaborating Sponsors:
Medtronic
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Brief Summary
Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the general population, but the causes and types of fatal arrhythmias they experience is unclear. The purpose of th...
Eligibility Criteria
Inclusion
- Greater than 18 years of age
- ESRD receiving hemodialysis for at least 3 months
Exclusion
- Inability to give informed consent
- Pre-existing implantable cardiac device (pacemaker or ICD) or imminent device implantation
- Imminent renal transplantation
- Life expectancy \< 1yr
- PT-INR or aPTT \> 1.7 upper limit of normal (ULN) or history of bleeding diathesis
- Unstable medical condition as deemed by primary nephrologist or study staff
- Known sustained ventricular tachycardia due to non-reversible cause.
- Active infection
- Known atrial fibrillation
- Women who are pregnant
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00932659
Start Date
June 1 2009
End Date
February 1 2011
Last Update
April 19 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710