EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
At a glance
Conditions
Where it's being run
15 sites across 14 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Rate of Device Malfunction adverse eventsUp to 90 days
A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee.
- Patient OutcomeUp to 90 days
Patient outcomes will be summarized as the proportion of subjects experiencing each outcome and the overall successful outcome. Successful outcome is defined as: * survival to recovery/successful weaning -or- * survival to explantation not attributed to device malfunction -or- * survival on EXCOR® Pediatric at 90 days post-implant Patients who are removed from support followed by death or for escalation to other therapy (such as another VAD or ECMO) due to major device malfunction attributed to the Active Driving System will be considered failures.
- Serious Adverse EventsUp to 90 days
Serious Adverse Event rates will be calculated as the rate per 100 patient-months for each individual event as defined in protocol.