PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
Recruiting · NCT06422871 · Observational (researchers observe without assigning treatment) · Lead sponsor: Merit Medical Systems, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
7 locations listed across 6 US states.
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- Sarasota Memorial Health Care System - Sarasota, Florida, United States
- WakeMed - Raleigh, North Carolina, United States
- University Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- Baylor Scott & White Heart and Vascular Hospital - Dallas - Dallas, Texas, United States
- Houston Methodist Hospital - Houston, Texas, United States
- Sentara Norfolk General Hospital - Norfolk, Virginia, United States