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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
HeRO® / Super HeRO® Subjects who meet all inclusion criteria and none of the exclusion criteria and treatment is attempted with the HeRO® Graft or Super HeRO® device.
  • Device: HeRO® Graft System or Super HeRO® System
    Treatment attempted with the HeRO® or Super HeRO® device.

Recruiting Locations

Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas 75226
Contact:
Stephen Hohmann, MD
214-820-2273
Stephen.hohmann@bswhealth.org

More Details

NCT ID
NCT06422871
Status
Recruiting
Sponsor
Merit Medical Systems, Inc.

Study Contact

Hannah Susmeyer
978-758-6166
Hannah.Susmeyer@merit.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center