Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06422871

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 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Access Failure Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HeRO® Graft System or Super HeRO® System

Device

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

Primary outcomes

  1. Composite Endpoint

    Time frame: 6 months

    Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia

Secondary outcomes

  1. Clinical Success

    Time frame: 12 and 24 months

  2. Proportion of subjects with primary patency

    Time frame: 6, 12 and 24 months

  3. Proportion of subjects with cumulative patency

    Time frame: 6, 12, and 24 months

  4. Device-related safety events

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Susmeyer

CONTACT

[email protected]

978-758-6166

Vicky Brunk, RN

CONTACT

[email protected]

717-873-3309

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Registry information

Official study title

PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis

Acronym: PReSeRVE-HD

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 21, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.