Observational study of HeRO Graft and Super HeRO in hemodialysis patients
PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
Merit Medical Systems, Inc. · NCT06422871
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merit Medical Systems, Inc. (industry) |
| Locations | 3 sites (Sarasota, Florida and 2 other locations) |
| Trial ID | NCT06422871 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this study focuses on specific devices, similar observational studies have shown promise in understanding the effectiveness of alternative dialysis access methods.
Eligibility criteria
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 this trial is running
Sarasota, Florida and 2 other locations
- Sarasota Memorial Health Care System — Sarasota, Florida, United States (RECRUITING)
- WakeMed — Raleigh, North Carolina, United States (RECRUITING)
- Baylor Scott & White Heart and Vascular Hospital - Dallas — Dallas, Texas, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Renal Disease, Hemodialysis Access Failure, HeRO