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Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.
Evaluation Design: This is a multi-center post market observational survey designed to collect procedural data on a minimum of 50 HeROâ„¢ patients in the commercialization phase. Data will be collected retrospectively for patients already implanted with the HeROâ„¢ device in the commercialization phase or prospectively for patients that receive the HeROâ„¢ Device during the data collection period. No special patient screening, testing, or procedures are required. There is no required patient follow-up.
Subject Population: Any patients the investigator deems/deemed eligible for HeROâ„¢ implant with complete procedural data are eligible for inclusion in this post market observational survey.
Endpoints: None
Inclusion/Exclusion Criteria: There are no formal screening criteria other than patients must have all required procedural data points available for recording on the case report form.
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| Measure | Description | Time Frame |
|---|---|---|
| Device placement success | End of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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End stage renal disease patients requiring vascular access
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| Name | Affiliation | Role |
|---|---|---|
| Marc Glickman, MD | Sentara Heart Hospital, Norfolk, VA | Principal Investigator |
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| Label | URL |
|---|---|
| Additional information regarding the HeRO Vascular Access Device | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |