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

Recruiting

• Conditions: End Stage Renal Disease; Hemodialysis Access Failure
• Interventions: Device: HeRO® Graft System or Super HeRO® System

• Registration Number: NCT06422871
• Lead Sponsor: Merit Medical Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Study Start: 2025-05-30
• Primary Completion: 2027-04-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Composite Endpoint	6 months	Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Baylor Scott & White Heart and Vascular Hospital - Dallas; 🇺🇸 Dallas, Texas, United States