End Stage Renal Failure on Dialysis
Conditions
Keywords
HeRO Graft
Brief summary
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
Detailed description
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
Interventions
DEVICEHeRO Graft implant for dialysis access
End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access
Sponsors
CryoLife, Inc.
Merit Medical Systems, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of dialysis (Kt/V) | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | 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. |
| Infection rate | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | To evaluate if the number of adverse events of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis. |
| Hospitalization rate | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | To evaluate if the hospitalization rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis. |
| Blood pressure | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | To evaluate if the blood pressure of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis. |
| Patency rate | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | To evaluate if the patency rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis. |
| Intervention rate | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years | To evaluate if the intervention rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis. |
Countries
United States
Outcome results
None listed