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

Description

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.

Conditions

End Stage Renal Disease, Hemodialysis Access Failure

Study Overview

Study Details

Study 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.

PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis

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

Condition
End Stage Renal Disease
Intervention / Treatment

-

Contacts and Locations

Dallas

Baylor Scott & White Heart and Vascular Hospital - Dallas, Dallas, Texas, United States, 75226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merit Medical Systems, Inc.,

Stephen Hohmann, MD, PRINCIPAL_INVESTIGATOR, Baylor Scott and White Health

Study Record Dates

2028-10-30