Skip to main content
OpenTrials
Completed

NCT Number: NCT01779856

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Renal Disease Arrhythmias, Cardiac Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chennai, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REVEAL Insertable Cardiac Monitor (ICM)

Device

Other names: Reveal ICM

Primary outcomes

  1. 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

  1. Collect the Number of Device and Procedure Related Adverse Events (AEs).

    Time frame: 6 months of dialysis data following Reveal ICM implant

    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.

  2. Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients

    Time frame: up to 6 months and through study completion

    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.

  3. Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed

    Time frame: 6 Month Follow-up

    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.

  4. Collect and Quantify the Episodes of Arrhythmias

    Time frame: 6 months of dialysis data following Reveal ICM implant

    The atrial arrhythmic events, ventricular arrhythmic events, and AF burden will be tabulated and reported.

  5. 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.

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Medtronic Corporate Technologies and New Ventures

Industry

Registry information

Official study title

Monitoring in Dialysis

Acronym: MiD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2013
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.