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

NCT06422871 | Recruiting FDA Device

• 1 other identifier: CVO-P4-23-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

End Stage Renal Disease; Hemodialysis Access Failure

Keywords

HeRO

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint

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

  6 months

Secondary Outcomes (4)

• Clinical Success

  12 and 24 months

• Proportion of subjects with primary patency

  6, 12 and 24 months

• Proportion of subjects with cumulative patency

  6, 12, and 24 months

• Device-related safety events

  24 months

Study Arms (1)

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

Interventions

HeRO® Graft System or Super HeRO® System DEVICE

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

HeRO® / Super HeRO®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (3)

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

RECRUITING

WakeMed

Raleigh, North Carolina, 27610, United States

RECRUITING

Baylor Scott & White Heart and Vascular Hospital - Dallas

Dallas, Texas, 75226, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Hohmann, MD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Susmeyer

CONTACT

978-758-6166; Hannah.Susmeyer@merit.com

Vicky Brunk, RN

CONTACT

717-873-3309; Vicky.Brunk@merit.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: July 28, 2025
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): December 28, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)