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

Last updated: May 6, 2025
Sponsor: Merit Medical Systems, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

HeRO® Graft System or Super HeRO® System

Clinical Study ID

NCT06422871
CVO-P4-23-02
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 deviceinstructions for use (IFU)

Exclusion

Key Exclusion Criteria:

  • Subject has a previously placed HeRO or Super HeRO device that is undergoingrevision or replacement

  • Subject has a topical or subcutaneous infection associated with the implantationsite

  • Subject has known or suspected systemic infection, bacteremia or septicemia

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: HeRO® Graft System or Super HeRO® System
Phase:
Study Start date:
May 30, 2025
Estimated Completion Date:
October 30, 2028

Connect with a study center

  • Baylor Scott & White Heart and Vascular Hospital - Dallas

    Dallas, Texas 75226
    United States

    Active - Recruiting

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