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PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
NCT06422871 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE HeRO® Graft System or Super HeRO® System
Study Locations (3)
Florida
- Sarasota Memorial Health Care System — Sarasota
North Carolina
- WakeMed — Raleigh
Texas
- Baylor Scott & White Heart and Vascular Hospital - Dallas — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-07-28 |
| Est. Completion | 2028-12-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06422871
The ClinicalTrials.gov registry entry for NCT06422871 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merit Medical Systems, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention — of which HeRO® Graft System or Super HeRO® System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06422871 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, North Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06422871 about?
NCT06422871 is a clinical study titled "PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis". 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 ...
What is the current status of trial NCT06422871?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2025-07-28. Estimated completion is 2028-12-28.
What conditions does trial NCT06422871 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Hemodialysis Access Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06422871?
The interventions under investigation include: HeRO® Graft System or Super HeRO® System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06422871?
This trial is sponsored by Merit Medical Systems, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06422871 being conducted?
This trial has 3 study locations across Florida, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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