An observational study in Arrhythmias, Cardiac, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-19.
Sponsored by Duke University · Observational
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 8 is below the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Duke hemodialysis patients with end stage renal disease
Exclusion Criteria:
This is a single arm observational study. The single arm consists of adult hemodialysis patients without a prior history of cardiac arrhythmias who will be implanted with a continuous cardiac monitoring device (REVEAL, Medtronic) for an FDA approved indication.
Device: continuous cardiac monitoring device (REVEAL, Medtronic)
hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up
Number of Participants With a Significant Arrhythmia Detected
Time frame: 6 months
Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias
Time frame: 6 months
Patients recruited from June 2009 to August 2010
| Milestone | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
| participants | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| Number of Participants With a Significant Arrhythmia Detected | 0 |
| participants | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm: Hemodialysis Patients Implanted With REVEAL Device | — | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age Continuous(years) | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| Mean | 55 ± 3 |
| Sex: Female, Male(Participants) | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| Female | 3 |
| Male | 5 |
| Region of Enrollment(participants) | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| United States | 8 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Duke University