End Stage Renal Disease
Conditions
Keywords
End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM
Brief summary
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.
Interventions
DEVICEREVEAL Insertable Cardiac Monitor (ICM)
Sponsors
Medtronic Corporate Technologies and New Ventures
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | 6 months of dialysis data following Reveal ICM implant | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collect the Number of Device and Procedure Related Adverse Events (AEs). | 6 months of dialysis data following Reveal ICM implant | 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. |
| Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | up to 6 months and through study completion | 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. |
| Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | 6 Month Follow-up | 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. |
| Collect and Quantify the Episodes of Arrhythmias | 6 months of dialysis data following Reveal ICM implant | The atrial arrhythmic events, ventricular arrhythmic events, and AF burden will be tabulated and reported. |
| 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. | 6 months | 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. |
Countries
India, United States
Participant flow
Recruitment details
Subjects on dialysis 3 times per week
Participants by arm
| Arm | Count |
|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.
REVEAL Insertable Cardiac Monitor (ICM) | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Delays in scheduling implant | 1 |
| Overall Study | Inclusion/Exclusion Not Met | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Subject ineligible for Implant | 2 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | REVEAL Insertable Cardiac Monitor (ICM) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants |
| Age, Continuous | 56.3 years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 28 Participants |
| Race/Ethnicity, Customized Black or African American | 39 Participants |
| Race/Ethnicity, Customized White or Caucasian | 7 Participants |
| Region of Enrollment India | 28 participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 81 |
| other Total, other adverse events | 8 / 81 |
| serious Total, serious adverse events | 28 / 81 |
Outcome results
Primary
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.
Time frame: 6 months of dialysis data following Reveal ICM implant
Population: 81 subjects were enrolled in the study; however, only 66 subjects were implanted with the device. This accounts for the difference in analyzed numbers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | CSA Subtype (Bradycardia) | 13 participants |
| REVEAL Insertable Cardiac Monitor (ICM) | Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | CSA Subtype (Asystole) | 6 participants |
| REVEAL Insertable Cardiac Monitor (ICM) | Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | CSA Subtype (Patient Marked Events) | 38 participants |
| REVEAL Insertable Cardiac Monitor (ICM) | Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | All CSA | 44 participants |
| REVEAL Insertable Cardiac Monitor (ICM) | Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device | CSA Subtype (VT) | 1 participants |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | 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. | R Value: R Wave Amplitude vs Potassium | -0.35 Correlation Coefficient |
| REVEAL Insertable Cardiac Monitor (ICM) | 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. | R Value: R Wave Amplitude vs Magnesium | -0.33 Correlation Coefficient |
| REVEAL Insertable Cardiac Monitor (ICM) | 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. | R Value: R Wave Amplitude vs. Phosphorus | -0.45 Correlation Coefficient |
Secondary
Collect and Quantify the Episodes of Arrhythmias
The atrial arrhythmic events, ventricular arrhythmic events, and AF burden will be tabulated and reported.
Time frame: 6 months of dialysis data following Reveal ICM implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | Collect and Quantify the Episodes of Arrhythmias | Ventricular Arrhythmia | 51 Arrhythmia Episodes |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect and Quantify the Episodes of Arrhythmias | Bradycardia | 17 Arrhythmia Episodes |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect and Quantify the Episodes of Arrhythmias | Asystole | 7 Arrhythmia Episodes |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect and Quantify the Episodes of Arrhythmias | Sinus Tachycardia | 53 Arrhythmia Episodes |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect and Quantify the Episodes of Arrhythmias | Overall Reviewer Confirmed Arrhythmias | 64 Arrhythmia Episodes |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect and Quantify the Episodes of Arrhythmias | Atrial Fibrillation Arrhythmia > 6 min | 60 Arrhythmia Episodes |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect and Quantify the Episodes of Arrhythmias | Patient Marked | 38 Arrhythmia Episodes |
Secondary
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.
Time frame: 6 months of dialysis data following Reveal ICM implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | Collect the Number of Device and Procedure Related Adverse Events (AEs). | Procedure Releated AEs | 3 Events |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect the Number of Device and Procedure Related Adverse Events (AEs). | Device Related AEs | 2 Events |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect the Number of Device and Procedure Related Adverse Events (AEs). | Not Related | 50 Events |
| REVEAL Insertable Cardiac Monitor (ICM) | Collect the Number of Device and Procedure Related Adverse Events (AEs). | Unknown | 2 Events |
Secondary
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.
Time frame: up to 6 months and through study completion
Population: Health-related events were recorded as they occurred. All health-related events were tabulated and summarized by type, time of occurrence, number of occurrences, and number of subjects affected. Summary statistics include events counts.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Inpatient : number of events reports | 33 number of events reported by |
| REVEAL Insertable Cardiac Monitor (ICM) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Emergency Department : number of events reports | 35 number of events reported by |
| REVEAL Insertable Cardiac Monitor (ICM) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Urgent Care : number of events reports | 57 number of events reported by |
| REVEAL Insertable Cardiac Monitor (ICM) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Out-Patient : number of events reports | 14 number of events reported by |
| All Available Time (up to 2 Years) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Urgent Care : number of events reports | 73 number of events reported by |
| All Available Time (up to 2 Years) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Inpatient : number of events reports | 44 number of events reported by |
| All Available Time (up to 2 Years) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Out-Patient : number of events reports | 15 number of events reported by |
| All Available Time (up to 2 Years) | Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients | Emergency Department : number of events reports | 42 number of events reported by |
Secondary
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.
Time frame: 6 Month Follow-up
Population: Reviewer confirmed arrhythmia rate normalized per hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| REVEAL Insertable Cardiac Monitor (ICM) | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | -2 Potassium Change | 0.015 arrhythmic events |
| REVEAL Insertable Cardiac Monitor (ICM) | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | 0 Potassium Change | 0.013 arrhythmic events |
| REVEAL Insertable Cardiac Monitor (ICM) | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | -1 Potassium Change | 0.014 arrhythmic events |
| All Available Time (up to 2 Years) | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | -2 Potassium Change | 0.023 arrhythmic events |
| All Available Time (up to 2 Years) | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | 0 Potassium Change | 0.02 arrhythmic events |
| All Available Time (up to 2 Years) | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | -1 Potassium Change | 0.015 arrhythmic events |
| Volume Removed 4.3 | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | -2 Potassium Change | 0.03 arrhythmic events |
| Volume Removed 4.3 | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | -1 Potassium Change | 0.016 arrhythmic events |
| Volume Removed 4.3 | Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed | 0 Potassium Change | 0.007 arrhythmic events |