Monitoring in Dialysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Medtronic Corporate Technologies and New Ventures
- Enrollment
- 81
- Primary Endpoint
- Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device
Time Frame: 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 Outcomes
- Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed(6 Month Follow-up)
- Collect and Quantify the Episodes of Arrhythmias(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.(6 months)
- Collect the Number of Device and Procedure Related Adverse Events (AEs).(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(up to 6 months and through study completion)