N/A
N=81
Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01779856 ↗Enrolled (actual)
81
Serious AEs
34.6%
Results posted
Feb 2021
Primary outcome: 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 — 44; 1; 13; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- REVEAL Insertable Cardiac Monitor (ICM) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medtronic Corporate Technologies and New Ventures
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
44; 1; 13; 6; 38 | — |
| SECONDARY Collect the Number of Device and Procedure Related Adverse Events (AEs). |
3; 2; 50; 2 | — |
| SECONDARY Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients |
33; 44; 14; 15; 35; 42 | — |
| SECONDARY Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed |
0.013; 0.02; 0.007; 0.014; 0.015; 0.016 | — |
| SECONDARY Collect and Quantify the Episodes of Arrhythmias |
64; 60; 51; 17; 7; 53 | — |
| 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. |
-0.35; -0.33; -0.45 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01779856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.