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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Florida
Sarasota Memorial Health Care System
RECRUITING
Sarasota
North Carolina
WakeMed
RECRUITING
Raleigh
Texas
Baylor Scott & White Heart and Vascular Hospital - Dallas
RECRUITING
Dallas
Contact Information
Primary
Hannah Susmeyer
Hannah.Susmeyer@merit.com
978-758-6166
Backup
Vicky Brunk, RN
Vicky.Brunk@merit.com
717-873-3309
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2028-12-28
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: Merit Medical Systems, Inc.

This content was sourced from clinicaltrials.gov