Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Characterization of Cardiac Arrhythmias in End Stage Kidney Disease Patients on Hemodialysis Using an Implantable Continuous Cardiac Rhythm Monitoring Device: A Pilot Study

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Device: continuous cardiac monitoring device (REVEAL, Medtronic)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodialysis patients<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Significant Arrhythmia Detected |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Stage Renal Disease, Hemodialysis, Cardiac Arrhythmias