PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HeRO® Graft System or Super HeRO® System.
- Who it may be relevant to
- Registry conditions: End Stage Renal Disease, Hemodialysis Access Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device HeRO® Graft System or Super HeRO® System
Treatment attempted with the HeRO® or Super HeRO® device.
Primary outcome measures
- Composite Endpoint [Time frame: 6 months]
Secondary outcome measures (4)
- Clinical Success [Time frame: 12 and 24 months]
- Proportion of subjects with primary patency [Time frame: 6, 12 and 24 months]
- Proportion of subjects with cumulative patency [Time frame: 6, 12, and 24 months]
- Device-related safety events [Time frame: 24 months]
Eligibility criteria
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)
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- MedStar Washington Hospital Center — Washington D.C.
- Sarasota Memorial Health Care System — Sarasota
- WakeMed — Raleigh
- University Pittsburgh Medical Center — Pittsburgh
- Baylor Scott & White Heart and Vascular Hospital - Dallas — Dallas
- Houston Methodist Hospital — Houston
- Sentara Norfolk General Hospital — Norfolk
Identifiers
NCT: NCT06422871 · CVO-P4-23-02