End Stage Renal DiseaseMiDNCT01779856

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

A study testing REVEAL Insertable Cardiac Monitor (ICM) in people with End Stage Renal Disease, run by Medtronic Corporate Technologies and New Ventures at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: REVEAL Insertable Cardiac Monitor (ICM)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 10 sitesin 2 countries
Study dates: Jan 2013to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States5 sites

Study site
Augusta, Georgia, 30901
Study site
Boston, Massachusetts, 02120
Study site
Chattanooga, Tennessee, 37408
Study site
Cincinnati, Ohio, 45267
Study site
Houston, Texas, 77030

Other trials in United States

India5 sites

Study site
Chennai, 600006
Study site
Gūrgaon, 122001
Study site
Hyderabad, 500034
Study site
New Delhi, 110070
Study site
New Delhi, 110076

Other trials in India

About this study

Official title: Monitoring in Dialysis

Conditions: End Stage Renal Disease
Being tested: REVEAL Insertable Cardiac Monitor (ICM)
Keywords: End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM
Medical subject headings: Kidney Failure, Chronic, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REVEAL Insertable Cardiac Monitor (ICM)Device
Also called Reveal ICM

Study groups in NCT01779856
Study group	Role	What they receive
REVEAL Insertable Cardiac Monitor (ICM)	Other	Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics. Receives: Device: REVEAL Insertable Cardiac Monitor (ICM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months of dialysis data following Reveal ICM implant

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Sep 2015

First posted30 Jan 2013 (estimated)
Study startJan 2013
Primary completionJul 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01779856
Sponsor's protocol ID: G120171
Acronym: MiD
Status last verified: Jan 2021
First submitted: 22 Jan 2013
Last updated: 15 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Soomro QH, Bansal N, Winkelmayer WC, Koplan BA, Costea AI, Roy-Chaudhury P, Tumlin JA, Kher V, Williamson DE, Pokhariyal S, McClure CK, Charytan DM; MiD Investigators. Association of Bradycardia and Asystole Episodes with Dialytic Parameters: An Analysis of the Monitoring in Dialysis (MiD) Study. Kidney360. 2022 Oct 11;3(11):1871-1880. doi: 10.34067/KID.0003142022. eCollection 2022 Nov 24.
PubMed 36514397
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.
PubMed 30836948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Monitoring in Dialysis
ClinicalTrials.gov ID: NCT01779856
Acronym / sponsor ID: MiD / G120171
Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Medtronic Corporate Technologies and New VenturesIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Jul 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 30 Jan 2013 (estimated)
Results: Posted 15 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
REVEAL Insertable Cardiac Monitor (ICM)	Other	Device: REVEAL Insertable Cardiac Monitor (ICM)Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REVEAL Insertable Cardiac Monitor (ICM)Also: Reveal ICM	Device	REVEAL Insertable Cardiac Monitor (ICM)

Primary outcome

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.

5 secondary outcomes

Collect the Number of Device and Procedure Related Adverse Events (AEs).
Time frame: 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
Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed
Time frame: 6 Month Follow-up
Collect and Quantify the Episodes of Arrhythmias
Time frame: 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

Results and safety

Results posted to the registry on 15 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
REVEAL Insertable Cardiac Monitor (ICM)	81	57

Primary outcome: 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. Number. Unit: participants

Measure	REVEAL Insertable Cardiac Monitor (ICM) n = 66
All CSA	44
CSA Subtype (VT)	1
CSA Subtype (Bradycardia)	13
CSA Subtype (Asystole)	6
CSA Subtype (Patient Marked Events)	38

Population analysed: 81 subjects were enrolled in the study; however, only 66 subjects were implanted with the device. This accounts for the difference in analyzed numbers.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through study completion, an average of 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
REVEAL Insertable Cardiac Monitor (ICM)	28 of 81 (34.6%)	8 of 81 (9.9%)	3 of 81

Limitations and caveats (from the sponsor): The intent of the project is to develop a foundation, which is scientifically based, to generate hypotheses resulting from data collected during theobservational study. Further research may be investigated based on the outcome of this small study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36514397Soomro QH, Bansal N, Winkelmayer WC, Koplan BA, Costea AI, Roy-Chaudhury P, Tumlin JA, Kher V, Williamson DE, Pokhariyal S, McClure CK, Charytan DM; MiD Investigators. Association of Bradycardia and Asystole Episodes with Dialytic Parameters: An Analysis of the Monitoring in Dialysis (MiD) Study. Kidney360. 2022 Oct 11;3(11):1871-1880. doi: 10.34067/KID.0003142022. eCollection 2022 Nov 24.
Derived from this study: PubMed 30836948Tumlin 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.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing REVEAL Insertable Cardiac Monitor (ICM) in people with End Stage Renal Disease, run by Medtronic Corporate Technologies and New Ventures at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01779856, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.