End Stage Renal Disease Clinical Trial
Official title:
HeRO Vascular Access Device Post Market Procedural Survey Protocol
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 HeRO™ patients in the commercialization phase.
Data will be collected retrospectively for patients already implanted with the HeRO™ device
in the commercialization phase or prospectively for patients that receive the HeRO™ 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 HeRO™ 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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