PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMerit Medical Systems, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Treatments tested in this trial
- HeRO® Graft System or Super HeRO® System
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov