Study the Characteristics of Cardiac Related Events in Hemodialysis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 21 September 2015
• Main ID: NCT01779856
• Date of registration: 22/01/2013
• Prospective Registration: No
• Primary sponsor: Medtronic Corporate Technologies and New Ventures
• Public title: Study the Characteristics of Cardiac Related Events in Hemodialysis Patients MiD
• Scientific title: Monitoring in Dialysis
• Date of first enrolment: January 2013
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01779856
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

India, United States

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

End Stage Renal Disease

Intervention(s)

Device: REVEAL Insertable Cardiac Monitor (ICM)

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

G120171

Source(s) of Monetary Support

Please refer to primary and secondary sponsors