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

Launched by MERIT MEDICAL SYSTEMS, INC. · May 15, 2024

Keywords

ClinConnect Summary

The PReSeRVE-HD study is looking at the safety and effectiveness of two medical devices called the HeRO Graft System and the Super HeRO Adaptor, which are used for patients on hemodialysis. These devices help people who have end-stage renal disease (a serious condition where the kidneys no longer work properly) maintain access for their dialysis treatment when other options have failed. This study will include adults aged 18 and older who are currently using one of these devices as part of their regular care.

Participants in the study will be monitored over two years, with four clinic visits to check their health and dialysis status. If they cannot attend a visit, researchers will follow up with them by phone. To join the study, individuals must provide consent and be receiving treatment with the HeRO Graft or Super HeRO, while those with certain infections or previous issues with these devices will not be eligible. The study is not yet recruiting participants, but it aims to gather important information that could help improve care for patients on hemodialysis.

Gender

ALL

Eligibility criteria

• Key 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)
• Key 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