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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Medtronic Corporate Technologies and New Ventures
Sponsor:
Information provided by (Responsible Party):
Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier:
NCT01779856
First received: January 22, 2013
Last updated: September 16, 2014
Last verified: September 2014
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779856

Contacts
Contact: Amy Roettger rs.dialysis.study@medtronic.com

Locations
United States, Georgia
Active, not recruiting
Augusta, Georgia, United States, 30901
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States, 02120
United States, Ohio
Active, not recruiting
Cincinnati, Ohio, United States, 45267
United States, Tennessee
Active, not recruiting
Chattanooga, Tennessee, United States, 37408
United States, Texas
Active, not recruiting
Houston, Texas, United States, 77030
India
Recruiting
Chennai, India, 600006
Not yet recruiting
Gurgaon, India, 122002
Recruiting
Gurgaon, India, 122001
Recruiting
Hyderabad, India, 500034
Recruiting
New Delhi, India, 110076
Recruiting
New Delhi, India, 110070
Sponsors and Collaborators
Medtronic Corporate Technologies and New Ventures
  More Information

No publications provided

Responsible Party: Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier: NCT01779856     History of Changes
Other Study ID Numbers: G120171
Study First Received: January 22, 2013
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

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
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014