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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
REVEAL Insertable Cardiac Monitor (ICM)
Sponsored by
Medtronic Corporate Technologies and New Ventures
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease focused on measuring End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

REVEAL Insertable Cardiac Monitor (ICM)

Arm Description

Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Collect and Quantify the Episodes of Arrhythmias
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.
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.

Full Information

First Posted
January 22, 2013
Last Updated
January 26, 2021
Sponsor
Medtronic Corporate Technologies and New Ventures
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1. Study Identification

Unique Protocol Identification Number
NCT01779856
Brief Title
Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.
Acronym
MiD
Official Title
Monitoring in Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Corporate Technologies and New Ventures

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REVEAL Insertable Cardiac Monitor (ICM)
Arm Type
Other
Arm Description
Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.
Intervention Type
Device
Intervention Name(s)
REVEAL Insertable Cardiac Monitor (ICM)
Other Intervention Name(s)
Reveal ICM
Primary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device
Description
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
Secondary Outcome Measure Information:
Title
Collect the Number of Device and Procedure Related Adverse Events (AEs).
Description
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
Title
Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients
Description
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
Title
Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed
Description
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
Title
Collect and Quantify the Episodes of Arrhythmias
Description
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
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Chennai
ZIP/Postal Code
600006
Country
India
City
Gurgaon
ZIP/Postal Code
122001
Country
India
City
Hyderabad
ZIP/Postal Code
500034
Country
India
City
New Delhi
ZIP/Postal Code
110070
Country
India
City
New Delhi
ZIP/Postal Code
110076
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
30836948
Citation
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.
Results Reference
derived

Learn more about this trial

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

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