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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeRO® Graft System or Super HeRO® System | Device | Treatment attempted with the HeRO® or Super HeRO® device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint | Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | 12 and 24 months | |
| Proportion of subjects with primary patency | 6, 12 and 24 months | |
| Proportion of subjects with cumulative patency |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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End-stage renal disease patients on hemodialysis who have exhausted all other access options.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Susmeyer | Contact | 978-758-6166 | Hannah.Susmeyer@merit.com | |
| Vicky Brunk, RN | Contact | 717-873-3309 | Vicky.Brunk@merit.com |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Hohmann, MD | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States | |
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| 6, 12, and 24 months |
| Device-related safety events | 24 months |
| Sarasota Memorial Health Care System |
| Recruiting |
| Sarasota |
| Florida |
| 34239 |
| United States |
| WakeMed | Recruiting | Raleigh | North Carolina | 27610 | United States |
| University Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15219 | United States |
| Baylor Scott & White Heart and Vascular Hospital - Dallas | Recruiting | Dallas | Texas | 75226 | United States |
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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