PReSeRVE-HD: Understanding HeRO® Grafts for Dialysis

This study, called PReSeRVE-HD, is an observational study looking at how well two medical devices, the HeRO® Graft System and the Super HeRO® System, work for people on hemodialysis (a treatment for kidney failure). These devices are used when other options for maintaining long-term dialysis access have not worked. The study aims to better understand the safety and performance of these devices. You could join if you are an adult (18 or older) with end-stage renal disease (kidney failure) on hemodialysis and are being treated with either the HeRO Graft or Super HeRO System. The study will measure a combined outcome (composite endpoint) at 6 months to see how successful the devices are. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 100 participants.
What's involved
You would be followed over 2 years, with 4 visit timepoints. If you don't have a standard clinic visit, you will be contacted by phone to check your health and dialysis status.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 2 years, with the primary endpoint measured at 6 months.

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NCT06422871

PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

Recruiting
Not specifiedAges 18+Observational
Merit Medical Systems, Inc.
~100 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:HeRO® Graft System or Super HeRO® System

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Endpoint
Measured over 6 months
End Stage Renal Disease
Hemodialysis Access Failure
7 sites across 6 states
Texas2
District of Columbia1
Florida1
North Carolina1
Pennsylvania1
Virginia1
  • Stephen Hohmann, MD · PRINCIPAL_INVESTIGATOR · Baylor Scott and White Health

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Eligibility criteria

Inclusion

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)

Exclusion

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
  • Composite Endpoint6 months

    Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia