Actively Recruiting
PReSeRVE-HD: Observational Study of the Merit HeRO Graft and Super HeRO Devices in Adults with End-Stage Renal Disease on Hemodialysis
Led by Merit Medical Systems, Inc. · Updated on 2026-06-01
100
Participants Needed
7
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with end-stage renal disease who require hemodialysis and have experienced failure of other dialysis access options. The study focuses on understanding how safe and effective the Merit Medical HeRO Graft System and Super HeRO Adaptor and Support Seal System devices are for maintaining long-term dialysis access when other options have failed. This observational study is sponsored by Merit Medical Systems, Inc.
CONDITIONS
Brief 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 18 years or older
- Subject has end-stage renal disease and is on hemodialysis
- Subject is treated with the 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 that is being revised or replaced
- Subject has a topical or subcutaneous infection at the device 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo treatment attempted with the HeRO® Graft or Super HeRO® device.
Visits at 6, 12, and 24 months for assessments
Duration - Up to 24 months
Participants are observed for device-related safety events and clinical success after device implementation.
Follow-up visits at 6, 12, and 24 months
Trial Site Locations
Total: 7 locations
1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Actively Recruiting
3
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
4
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
5
Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas, United States, 75226
Actively Recruiting
6
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
7
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
H
Hannah Susmeyer
V
Vicky Brunk, RN
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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