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

Merit Medical Systems, Inc.

Overview

Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including: * Post-operative complications for HeRO Graft implantation * Length of time between insertion and use of HeRO Graft * Incidence of thrombosis * Hospitalizations * Incidence of infections and other adverse event occurrence * Mortality * Hemoglobin * Kt/V * pre-dialysis blood pressure * post-dialysis blood pressure * blood flow rate and * dialysis flow rate

Study Type

OBSERVATIONAL

Conditions

End Stage Renal Failure on Dialysis

Interventions

HeRO Graft implant for dialysis accessDEVICE

End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients eligible for HeRO Graft for dialysis access * Age greater than 18 years old * Able to give informed consent Exclusion Criteria: * Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures; * Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.

Locations (3)

Duke University Medical Center

Durham, North Carolina, United States

Baylor Research Institute

Dallas, Texas, United States

Sentara Medical Group Sentara Vascular Specialists

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

Mortality

To evaluate if the death rate of participants using the HeRO Graft is less than the death rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.

Time frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Secondary Outcomes

Adequacy of dialysis (Kt/V)

To evaluate if the adequacy of dialysis of participants using the HeRO Graft is better than the adequacy of dialysis of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.

Time frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Infection rate

To evaluate if the infection rate of participants using the HeRO Graft is less than the infection rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.

Time frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Data from ClinicalTrials.gov

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