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

NCT01779856 | Completed Results DMC FDA Device

• 1 other identifier: G120171
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 10

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.

Conditions

End Stage Renal Disease

Keywords

End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM

Outcome Measures

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

  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 Outcomes (5)

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

  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

  up to 6 months and through study completion

• Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed

  6 Month Follow-up

• Collect and Quantify the Episodes of Arrhythmias

  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.

  6 months

Study Arms (1)

REVEAL Insertable Cardiac Monitor (ICM)

OTHER

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

Device: REVEAL Insertable Cardiac Monitor (ICM)

Interventions

REVEAL Insertable Cardiac Monitor (ICM) DEVICE

Also known as: Reveal ICM

REVEAL Insertable Cardiac Monitor (ICM)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Corporate Technologies and New Ventures: lead

Study Sites (10)

Unknown Facility

Augusta, Georgia, 30901, United States

Location

Unknown Facility

Boston, Massachusetts, 02120, United States

Location

Unknown Facility

Cincinnati, Ohio, 45267, United States

Location

Unknown Facility

Chattanooga, Tennessee, 37408, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Chennai, 600006, India

Location

Unknown Facility

Gūrgaon, 122001, India

Location

Unknown Facility

Hyderabad, 500034, India

Location

Unknown Facility

New Delhi, 110070, India

Location

Unknown Facility

New Delhi, 110076, India

Location

Related Publications (2)

• 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.

  PMID: 36514397 DERIVED

• 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.

  PMID: 30836948 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: RCS Sr. Director of Medical Affairs
• Organization: Medtronic, plc

amy.denise.roettger@medtronic.com

763-505-4566

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 15, 2021
• Results First Posted: February 15, 2021

Record last verified: 2021-01

Locations

IN (5); US (5)