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PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
Sponsor: Merit Medical Systems, Inc.
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.
Official title: PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-07-28
Completion Date
2028-12-28
Last Updated
2025-08-05
Healthy Volunteers
No
Interventions
HeRO® Graft System or Super HeRO® System
Treatment attempted with the HeRO® or Super HeRO® device.
Locations (3)
Sarasota Memorial Health Care System
Sarasota, Florida, United States
WakeMed
Raleigh, North Carolina, United States
Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas, United States