NCT06422871

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	HeRO® Graft System or Super HeRO® System	Treatment attempted with the HeRO® or Super HeRO® device.

Timeline

• Start date: 2025-07-28
• Primary completion: 2027-06-28
• Completion: 2028-12-28
• First posted: 2024-05-21
• Last updated: 2025-08-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study