Observational study of HeRO Graft and Super HeRO in hemodialysis patients
Official title: PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
Run by Merit Medical Systems, Inc. · NCT06422871 · Data updated 2026-11-12
This study is testing how safe and effective the HeRO Graft System and Super HeRO Adaptor are for adults on hemodialysis who have run out of other options for dialysis access.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Merit Medical Systems, Inc. Industry-sponsored |
| Locations | 7 sites (Washington D.C., District of Columbia and 6 other locations) |
| Status | Recruiting |
| Started | July 28, 2025 |
| Main results expected | June 28, 2027 |
| Study ends | December 28, 2028 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT06422871 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with end-stage renal disease who are currently treated with the HeRO Graft or Super HeRO System.
✕Probably not a fit
Patients with a previously placed HeRO or Super HeRO device undergoing revision or replacement, or those with infections related to the implantation site, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enhance understanding of the safety and performance of the HeRO Graft System and Super HeRO Adaptor in adults undergoing hemodialysis. Participants will be those who have exhausted all other dialysis access options and are currently using these devices as part of their routine medical care. The study will involve regular clinic visits over two years, with follow-up phone calls to monitor health and dialysis status if clinic visits are missed.
Why it matters
Potential benefit: If successful, this study could improve long-term dialysis access solutions for patients with end-stage renal disease.
How similar studies have gone: While this study focuses on specific devices, similar observational studies have shown promise in understanding the effectiveness of alternative dialysis access methods.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States Recruiting -
Sarasota Memorial Health Care System
Sarasota, Florida, United States Recruiting -
WakeMed
Raleigh, North Carolina, United States Recruiting -
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Recruiting -
Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas, United States Recruiting -
Houston Methodist Hospital
Houston, Texas, United States Recruiting
Show 1 more location
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Sentara Norfolk General Hospital
Norfolk, Virginia, United States Recruiting
Study contacts
- Principal investigator: Stephen Hohmann, MD — Baylor Scott and White Health
- Study coordinator: Hannah Susmeyer
- Email: Hannah.Susmeyer@merit.com
- Phone: 978-758-6166
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.