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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT02481206
Eligibility Criteria:
Inclusion Criteria:
* End stage renal disease (ESRD) requiring hemodialysis
* On hemodialysis for ≤ 2 calendar months or scheduled to begin hemodialysis within 1 calendar month
* ≥50 years of age
* Documented Ejection Fraction \> 35% within the previous calendar year
* \- If the patient has been hospitalized for a myocardial infarction or heart failure decompensation, the Ejection Fraction measurement must have occurred during the last hospitalization or after discharge
Exclusion Criteria:
* Is receiving or will receive hemodialysis due to acute kidney injury and is not expected to receive subsequent chronic hemodialysis therapy
* Patient has an active ICD
* Patient has a unipolar pacemaker
* Patient has physical or mental conditions preventing him/her from interacting with or wearing a Wearable Cardioverter Defibrillator
* Patient has a chest circumference at the level of the xiphoid of \< 24 inches
* Patient has a chest circumference at the level of the xiphoid of \> 56 inches
* Patient has an advance directive prohibiting resuscitation
* Patient has cancer or other terminal disease (excluding ESRD) with expected survival less than 6 months
* Patient is medically unstable for reasons not specifically related to kidney disease
* Patient is scheduled for live-donor kidney transplantation within 6 calendar months
* Patient is unable to consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02481206
Study Brief:
Protocol Section:
NCT02481206