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| Name | Class |
|---|---|
| CryoLife, Inc. | INDUSTRY |
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Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeRO Graft | End stage renal disease patients who receive HeRO Graft implant for dialysis access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeRO Graft implant for dialysis access | Device | End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization rate | 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. | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years |
Inclusion Criteria:
Exclusion Criteria:
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All patients eligible for HeRO Graft for dialysis access
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Lawson, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Baylor Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22580402 | Background | Gage SM, Katzman HE, Ross JR, Hohmann SE, Sharpe CA, Butterly DW, Lawson JH. Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] graft implants for hemodialysis treatment. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):93-9. doi: 10.1016/j.ejvs.2012.04.011. Epub 2012 May 12. | |
| 19628360 | Background |
| Label | URL |
|---|---|
| HeRO Graft website | View source |
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| 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 |
| Patency rate |
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. |
| Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years |
| Intervention rate | 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. | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years |
| Adverse events | 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. | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years |
| Blood pressure | 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. | Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years |
| Dallas |
| Texas |
| 75246 |
| United States |
| Sentara Medical Group Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Katzman HE, McLafferty RB, Ross JR, Glickman MH, Peden EK, Lawson JH. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg. 2009 Sep;50(3):600-7, 607.e1. doi: 10.1016/j.jvs.2009.04.014. Epub 2009 Jul 22. |
| 24428351 | Background | Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310-8. doi: 10.1111/sdi.12173. Epub 2014 Jan 15. |