XPLORE2/PIVOTAL STUDY OVERVIEW

50Patients

Patients aged 2-21 years old requiring RVOT reconstruction *
*Inclusion and exclusion criteria apply

Up to15sites in USA, Europe, Asia

Principal Investigator: Dr David Morales – Cincinnati Children’s Hospital Medical Center

PRIMARY ENDPOINTS
Composite rate of device related events (deaths, re-operations or re-interventions) at 12-month follow-up
SECONDARY ENDPOINTS

Overall rate of subjects who require re-operation or re-intervention due to device failure at 6 months

Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6- and 12-month follow-up

Overall rate of mortality at 60-month follow-up post implantation

Overall rate of subjects with a mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mmHg at 6- and 12-month follow-up

Overall rate of device-related deaths due to device failure at 6-month follow-up post implantation
INCLUSION CRITERIA
Patients requiring correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) due to congenital heart malformations. This includes patients in need of replacement of a previously implanted, but dysfunctional, homograft / pulmonary valved conduit, as well as patients undergoing a Ross procedure.
EXCLUSION CRITERIA*
*Disclaimer: This is only a selection of key criteria. Please consult the participating research centers or clinicaltrials.gov for more information.