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PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

Recruitingn/aAges 18 Years - anyAllMerit Medical Systems, Inc.
NCT06422871 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • HeRO® Graft System or Super HeRO® System
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Where

7 sites
MedStar Washington Hospital Center
Washington D.C., United States
Sarasota Memorial Health Care System
Sarasota, United States
WakeMed
Raleigh, United States
University Pittsburgh Medical Center
Pittsburgh, United States
Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, United States
Houston Methodist Hospital
Houston, United States
Sentara Norfolk General Hospital
Norfolk, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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