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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
81
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Chattanooga, Tennessee, United States
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
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
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
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
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Unnamed facility
Houston, Texas, United States
Unnamed facility
Chennai, India
Unnamed facility
Gurgaon, India
Unnamed facility
Hyderabad, India
Unnamed facility
New Delhi, India
Unnamed facility
New Delhi, India
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
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