End Stage Renal Disease, Hemodialysis Access Failure
Conditions
Keywords
HeRO
Brief summary
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.
Interventions
DEVICEHeRO® Graft System or Super HeRO® System
Treatment attempted with the HeRO® or Super HeRO® device.
Sponsors
Merit Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subject provides written informed consent * Subject is ≥ 18 years * Subject is end-stage renal disease patient on hemodialysis. * Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU) Key
Exclusion criteria
* Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement * Subject has a topical or subcutaneous infection associated with the implantation site * Subject has known or suspected systemic infection, bacteremia or septicemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint | 6 months | Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Success | 12 and 24 months |
| Proportion of subjects with primary patency | 6, 12 and 24 months |
| Proportion of subjects with cumulative patency | 6, 12, and 24 months |
| Device-related safety events | 24 months |
Countries
United States
Contacts
CONTACTHannah Susmeyer
CONTACTVicky Brunk, RN
PRINCIPAL_INVESTIGATORStephen Hohmann, MD
Baylor Scott and White Health
Outcome results
None listed