NCT06422871Recruiting

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

Merit Medical Systems, Inc.

Start Date

7/28/2025

Completion Date

12/28/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

HeRO® Graft System or Super HeRO® System

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

End Stage Renal DiseaseHemodialysis Access Failure

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Sarasota Memorial Health Care System

Sarasota, Florida 34239

United States

WakeMed

Raleigh, North Carolina 27610

United States

University Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15219

United States

Baylor Scott & White Heart and Vascular Hospital - Dallas

Dallas, Texas 75226

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States