HeRO Vascular Access Device Post Market Procedural Survey Protocol (PPS)
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.
End Stage Renal Disease
|Study Design:||Observational Model: Cohort|
|Official Title:||HeRO Vascular Access Device Post Market Procedural Survey Protocol|
- Device placement success [ Time Frame: End of procedure ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889291
|Principal Investigator:||Marc Glickman, MD||Sentara Heart Hospital, Norfolk, VA|