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

January 26, 2021 updated by: Medtronic Corporate Technologies and New Ventures

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
6 months of dialysis data following Reveal ICM implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
up to 6 months and through study completion
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.
6 Month Follow-up
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.
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.
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Corporate Technologies and New Ventures

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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