Actively Recruiting
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
Led by Merit Medical Systems, Inc. · Updated on 2025-08-05
100
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject provides written informed consent
- Subject is 65 18 years old
- Subject is an end-stage renal disease patient on hemodialysis
- Subject is treated with HeRO Graft or Super HeRO System according to device instructions for use
You will not qualify if you...
- Subject has a previously placed HeRO or Super HeRO device undergoing revision or replacement
- Subject has a topical or subcutaneous infection at the implantation site
- Subject has known or suspected systemic infection, bacteremia, or septicemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Actively Recruiting
2
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
3
Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas, United States, 75226
Actively Recruiting
Research Team
H
Hannah Susmeyer
CONTACT
V
Vicky Brunk, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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