RecruitingNCT06422871

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


Sponsor

Merit Medical Systems, Inc.

Enrollment

100 participants

Start Date

Jul 28, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients who have received a special type of dialysis access device called the HeRO Graft or Super HeRO System — used when standard dialysis access (like a fistula or regular graft) is no longer possible due to blocked veins. The study aims to collect real-world data on how well these devices work and how safe they are over time. **You may be eligible if...** - You are 18 or older - You have end-stage kidney disease and are on hemodialysis - You have received a HeRO Graft or Super HeRO System device according to standard instructions - You can provide written consent **You may NOT be eligible if...** - You are having a previously placed HeRO or Super HeRO device revised or replaced (not a new placement) - You have a skin or tissue infection at the device implant site - You have a known or suspected systemic infection, bacteria in the blood, or sepsis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHeRO® Graft System or Super HeRO® System

Treatment attempted with the HeRO® or Super HeRO® device.


Locations(3)

Sarasota Memorial Health Care System

Sarasota, Florida, United States

WakeMed

Raleigh, North Carolina, United States

Baylor Scott & White Heart and Vascular Hospital - Dallas

Dallas, Texas, United States

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NCT06422871


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