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

Monitoring in Dialysis

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 Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: REVEAL Insertable Cardiac Monitor (ICM)

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chennai, India, 600006
  • Gurgaon, India, 122001
  • Hyderabad, India, 500034
  • New Delhi, India, 110076
  • New Delhi, India, 110070
• United States
  • Georgia
    • Augusta, Georgia, United States, 30901
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
  • Ohio
    • Cincinnati, Ohio, United States, 45267
  • Tennessee
    • Chattanooga, Tennessee, United States, 37408
  • Texas
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: REVEAL Insertable Cardiac Monitor (ICM); Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.	Device: REVEAL Insertable Cardiac Monitor (ICM); Other Names: Reveal ICM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Corporate Technologies and New Ventures

Publications and helpful links

General Publications

• Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S, Charytan DM; MiD investigators and Committees. Relationship between dialytic parameters and reviewer confirmed arrhythmias in hemodialysis patients in the monitoring in dialysis study. BMC Nephrol. 2019 Mar 5;20(1):80. doi: 10.1186/s12882-019-1212-6.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: G120171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes