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

Study Overview
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Brief Summary
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Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

Detailed Description
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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

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

Conditions
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End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Device: HeRO Graft implant for dialysis access


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HeRO Graft<br>End stage renal disease patients who receive HeRO Graft implant for dialysis access | Device: HeRO Graft implant for dialysis access<br>* End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeRO Graft