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NCT00932659 · ClinicalTrials.gov registry record
Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 8
- Enrollment target
NCT00932659 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 8 participants.
The verdict
NCT00932659 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study 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 this prospective observational cohort study is to capture and characterize occult arrhythmias which occur in hemodialysis patients over a 6 month period. After informed consent and baseline assessment, 30 adult hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device (REVEAL, Medtronic). Three followup visits will be scheduled to download device data and quantify the number of potentially malignant arrhythmias which occur in study subjects during the 6 month period. Additionally, captured events will be monitored remotely via regular patient initiated transmission of device data every 2 weeks. Any serious occult arrhythmias detected will be immediately acted upon with a predefined management algorithm. Descriptive data and simple proportions will be used to describe the incidence and types of arrhythmias among the study cohort. Risks of this study include 1) potential loss of patient confidentiality 2) risks related to insertion of device including pocket hematoma, device infection, pain and discomfort secondary to procedure. These will be minimized by strict security measures to protect each patient's protected health information (PHI), preprocedural screening and insertion of monitoring devices by highly trained operators, and frequent careful direct patient followup.
Interventions
- DEVICE continuous cardiac monitoring device (REVEAL, Medtronic)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00932659
The ClinicalTrials.gov registry entry for NCT00932659 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which continuous cardiac monitoring device (REVEAL, Medtronic) is the first listed.
NCT00932659 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00932659 about?
NCT00932659 is a clinical study titled "Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients". 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 this prospective observational cohort study is to capture and characterize occult arrhythmias which oc...
What is the current status of trial NCT00932659?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2009-06. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00932659?
The interventions under investigation include: continuous cardiac monitoring device (REVEAL, Medtronic) (DEVICE).
Who is sponsoring clinical trial NCT00932659?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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