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

July 31, 2025 updated by: Merit Medical Systems, Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Health Care System
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed
    • Texas
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott & White Heart and Vascular Hospital - Dallas
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

End-stage renal disease patients on hemodialysis who have exhausted all other access options.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HeRO® / Super HeRO®
Subjects who meet all inclusion criteria and none of the exclusion criteria and treatment is attempted with the HeRO® Graft or Super HeRO® device.
Device: HeRO® Graft System or Super HeRO® System
Treatment attempted with the HeRO® or Super HeRO® device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Endpoint
Time Frame: 6 months
Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Device-related safety events
Time Frame: 24 months
24 months
Clinical Success
Time Frame: 12 and 24 months
12 and 24 months
Proportion of subjects with primary patency
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Proportion of subjects with cumulative patency
Time Frame: 6, 12, and 24 months
6, 12, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merit Medical Systems, Inc.

Investigators

  • Principal Investigator: Stephen Hohmann, MD, Baylor Scott and White Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2025

Primary Completion (Estimated)

June 28, 2027

Study Completion (Estimated)

December 28, 2028

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVO-P4-23-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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