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

Merit Medical Systems

Status: Enrolling

Conditions: End Stage Renal Disease; Hemodialysis Access Failure

Treatments: Device: HeRO® Graft System or Super HeRO® System

Study type: Observational

Funder types: Industry

Identifiers

NCT06422871

CVO-P4-23-02

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 1 patient group

HeRO® / Super HeRO®

Description:

Subjects who meet all inclusion criteria and none of the exclusion criteria and treatment is attempted with the HeRO® Graft or Super HeRO® device.

Treatment:

Device: HeRO® Graft System or Super HeRO® System