Recruiting

HeRO & Super HeRO

Sponsor:

Merit Medical Systems, Inc.

Code:

NCT06422871

Conditions

End Stage Renal Disease

Hemodialysis Access Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HeRO® Graft System or Super HeRO® System

Study Details

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

Study ID

NCT06422871

Start date

Jul 28, 2025

Status verified date

May, 2026

Completion date

Dec 28, 2028

Anticipated

Primary completion date

Jun 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

HeRO® Graft System or Super HeRO® System

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

Primary outcome measure

  • Composite Endpoint [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Hannah Susmeyer

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

Vicky Brunk, RN

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

Locations

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Sarasota Memorial Health Care System

Recruiting

Sarasota, Florida, United States, 34239

WakeMed

Recruiting

Raleigh, North Carolina, United States, 27610

University Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Baylor Scott & White Heart and Vascular Hospital - Dallas

Recruiting

Dallas, Texas, United States, 75226

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

Merit Medical Systems, Inc.

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • HeRO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merit Medical Systems, Inc. on 2026-06-01.