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Study the Characteristics of Cardiac Related Events in Hemodialysis Patients (MiD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779856
First Posted: January 30, 2013
Last Update Posted: September 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Corporate Technologies and New Ventures
  Purpose
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.

Condition Intervention
End Stage Renal Disease Device: REVEAL Insertable Cardiac Monitor (ICM)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Monitoring in Dialysis

Resource links provided by NLM:


Further study details as provided by Medtronic Corporate Technologies and New Ventures:

Primary Outcome Measures:
  • Estimate the proportion of hemodialysis patients who experience 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 Outcome Measures:
  • Collect the number of device and procedure related adverse events (AEs). [ Time Frame: 6 months of dialysis data following Reveal ICM implant ]
  • Correlate clinically significant arrhythmias (as defined above) to hemodialysis session parameters and health-related events associated with ESRD. [ Time Frame: 6 months of dialysis data following Reveal ICM implant ]

Enrollment: 81
Study Start Date: January 2013
Study Completion Date: September 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Reveal ICM

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779856


Locations
United States, Georgia
Augusta, Georgia, United States, 30901
United States, Massachusetts
Boston, Massachusetts, United States, 02120
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Tennessee
Chattanooga, Tennessee, United States, 37408
United States, Texas
Houston, Texas, United States, 77030
India
Chennai, India, 600006
Gurgaon, India, 122001
Hyderabad, India, 500034
New Delhi, India, 110070
New Delhi, India, 110076
Sponsors and Collaborators
Medtronic Corporate Technologies and New Ventures
  More Information

Responsible Party: Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier: NCT01779856     History of Changes
Other Study ID Numbers: G120171
First Submitted: January 22, 2013
First Posted: January 30, 2013
Last Update Posted: September 10, 2015
Last Verified: September 2015

Keywords provided by Medtronic Corporate Technologies and New Ventures:
End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency