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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-28

Study Completion Date

2028-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis

NCT01343251

End Stage Renal Disease (ESRD)

COMPLETED

Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

NCT02164175

End Stage Renal Failure on Dialysis

WITHDRAWN

Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

NCT00890045

Renal Failure Chronic Requiring Hemodialysis

COMPLETED NA

Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]

NCT02532621

End Stage Renal Disease

COMPLETED NA

Evaluation of STARgraft-3 for Hemodialysis

NCT05729620

End Stage Renal Disease

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease Hemodialysis Access Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

HeRO® Graft System or Super HeRO® System

Intervention Type DEVICE

Treatment attempted with the HeRO® or Super HeRO® device.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HeRO® Graft System or Super HeRO® System

Treatment attempted with the HeRO® or Super HeRO® device.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No