Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

End Stage Renal Disease Clinical Trial

— PReSeRVE-HD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422871
• Other study ID #: CVO-P4-23-02
• Status: Not yet recruiting
• Start date: February 15, 2025
• Est. completion date: July 15, 2028

Study information

• Verified date: May 2024
• Source: Merit Medical Systems, Inc.
• Contact: PReSeRVE-HD Clinical Affairs Team
• Phone: 978-758-6166
• Email: PReSeRVE-HDclinical[@]merit.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. Patients in the study will return to their study center 4 times over 2 years for follow-up visits to check their current health and dialysis status.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: July 15, 2028
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis Access Failure
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• HeRO® Graft System or Super HeRO® System
Treatment attempted with the HeRO® or Super HeRO® device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness Endpoint	Proportion of subjects with cumulative patency	6 months
Primary	Safety Endpoint	Proportion of subjects with device-related infection-free survival	6 months
Secondary	Proportion of subjects with primary patency		12 and 24 months
Secondary	Proportion of subjects with cumulative patency		12 and 24 months
Secondary	Device-related safety events		24 months