Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.

Study Overview
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Brief Summary
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The primary objective of this study is to estimate the proportion of hemodialysis patients experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor (ICM) device.

Official Title
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Monitoring in Dialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: REVEAL Insertable Cardiac Monitor (ICM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years of age or older and is willing to be implanted with the Reveal ICM Currently on hemodialysis at least three times per week OR has an estimated glomerular filtration rate (eGFR) of < 15 mL/min/1.73m^2 and is expected to begin hemodialysis within 2 months. Subject is willing and able to comply with the protocol Exclusion Criteria: Currently enrolled in an interventional study that may interfere with the Monitoring in Dialysis protocol Not suitable for Reveal ICM implantation Has an existing hemodialysis catheter that may interfere with the Reveal ICM implantation site Has a recent infection Is currently on hemodialysis with a hemoglobin < 10 g/dL Has end-stage liver failure or has had thoracic surgery within the past 6 months Has an existing pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization device Is scheduled for renal transplantation or will likely be transplanted within 6 months Is currently on home hemodialysis

Ages Eligible for Study
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Minimum Age: 21 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: REVEAL Insertable Cardiac Monitor (ICM)<br>Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. | Device: REVEAL Insertable Cardiac Monitor (ICM)<br> <br> * Other names: Reveal ICM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | Events defined as clinically significant for the objective include: episodes of ventricular tachycardia (VT) greater than or equal to 130 beats per minute (BPM), episodes of bradycardia indicated by a recorded heart rate less than or equal to 40 BPM, instances of asystole lasting at least three seconds, or any symptomatic event, indicated by patient use of the Reveal ICM Patient Assistant, where review of the stored ECG shows an arrhythmia considered clinically significant in the judgement of the study site cardiologist. | 6 months of dialysis data following Reveal ICM implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect the Number of Device and Procedure Related Adverse Events (AEs). | All procedure and device-related AEs will be recorded as they occur, and will be categorized according to seriousness, intensity, and relatedness to the device, device components, or implant procedure. | 6 months of dialysis data following Reveal ICM implant | 
| Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Health-related events were recorded as they occurred. All health-related events were tabulated and summarized by type, time of occurrence (first 6 months and All Available Time (up to 2 years) and number of subjects affected. | up to 6 months and through study completion | 
| Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | The atrial arrhythmic events, ventricular arrhythmic events, and AF burden were tabulated and reported. Atrial arrhythmic episodes were distributed temporally over the inter- and intradialytic periods using the negative binomial mixed effect regression model as described above in the primary objective analysis. | 6 Month Follow-up | 
| Collect and Quantify the Episodes of Arrhythmias | The atrial arrhythmic events, ventricular arrhythmic events, and AF burden will be tabulated and reported. | 6 months of dialysis data following Reveal ICM implant | 
| Assess Whether the Morphology of ECG Recordings Captured by the Reveal ICM Device Correlate With Serum Electrolyte Levels Measured Just Before and Just After Dialysis Sessions. | The Reveal patient Assistant will be used to trigger memory storage of 7.5 minute ECG recordings in conjunction with serum electrolyte measurements taken before and after selected dialysis sessions. Measures of ECG morphology (e.g., QT interval, QT dispersion, QRS width, T-wave amplitude) will then be extracted from the recorded ECG data. The serum electrolyte data will also be included. | 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, Arrhythmia, Reveal ICM