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

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT01779856

Run by

Medtronic Corporate Technologies and New Ventures

People needed

81

Starts

2013-01-01

Expected to finish

2015-09-01

Last updated by the study team

2021-02-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• Study site — Augusta, Georgia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Chennai, India
• Study site — Gurgaon, India
• Study site — Hyderabad, India
• Study site — New Delhi, India
• Study site — New Delhi, India

Full record on ClinicalTrials.gov

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