Arrhythmias, Cardiac
Conditions
Keywords
End-Stage Renal Disease, Hemodialysis, Cardiac Arrhythmias
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 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
DEVICEcontinuous 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
Sponsors
Medtronic
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 18 years of age * ESRD receiving hemodialysis for at least 3 months
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With a Significant Arrhythmia Detected | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias | 6 months |
Countries
United States
Participant flow
Recruitment details
Patients recruited from June 2009 to August 2010
Participants by arm
| Arm | Count |
|---|---|
| Single Arm: Hemodialysis Patients Implanted With REVEAL Device adult hemodialysis patients without a prior history of cardiac arrhythmias
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 | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Single Arm: Hemodialysis Patients Implanted With REVEAL Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 55 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Number of Participants With a Significant Arrhythmia Detected
Time frame: 6 months
Population: All patients enrolled were analyzed in this observational study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm: Hemodialysis Patients Implanted With REVEAL Device | Number of Participants With a Significant Arrhythmia Detected | 0 participants |
Secondary
Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias
Time frame: 6 months
Population: all participants included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm: Hemodialysis Patients Implanted With REVEAL Device | Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias | 0 participants |