Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01779856
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01779856
Study Brief:
Protocol Section:
NCT01779856