The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.
Study Type
OBSERVATIONAL
Enrollment
100
Treatment attempted with the HeRO® or Super HeRO® device.
Sarasota Memorial Health Care System
Sarasota, Florida, United States
RECRUITINGWakeMed
Raleigh, North Carolina, United States
RECRUITINGBaylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas, United States
RECRUITINGComposite Endpoint
Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia
Time frame: 6 months
Clinical Success
Time frame: 12 and 24 months
Proportion of subjects with primary patency
Time frame: 6, 12 and 24 months
Proportion of subjects with cumulative patency
Time frame: 6, 12, and 24 months
Device-related safety events
Time frame: 24 months
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