NCT06422871Recruiting
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 May 2024
- Start date
- 28 Jul 2025
- Primary completion date
- 28 Jun 2027
- Lead sponsor
- Merit Medical Systems, Inc.
- Diseases
- Chronic kidney disease
- NCT number
- NCT06422871
What you commit to
- Study type: Observational
- Planned participants: 100
- From 28 Jul 2025 to the primary completion date, 28 Jun 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement
Other illness
- Subject has a topical or subcutaneous infection associated with the implantation site
- Subject has known or suspected systemic infection, bacteremia or septicemia
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor Scott & White Heart and Vascular Hospital - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Sentara Norfolk General Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| University Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Wakemed Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Sarasota Memorial Health Care System Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.