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
This trial does not accept healthy volunteersQualifiers
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 population
End-stage renal disease patients on hemodialysis who have exhausted all other access options.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
HeRO® Graft System or Super HeRO® System
DeviceTreatment attempted with the HeRO® or Super HeRO® device.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: HeRO® / Super HeRO®1 intervention
Trial outcomes
Primary outcomes
1
Composite Endpoint
Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia
Time frame
6 monthsSecondary outcomes
1
Clinical Success
Time frame
12 and 24 months2
Proportion of subjects with primary patency
Time frame
6, 12 and 24 months3
Proportion of subjects with cumulative patency
Time frame
6, 12, and 24 months4
Device-related safety events
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov