Gender Does Matter: Gender-Specific Outcome Analysis of 67.000 Hearts from the ISHLT Registry

patient was successfully implanted and managed with a VentrAssist VAD. From this positive experience, the DEFINe study was created. Results: The DEFINe study was developed, and approved by the FDA (IDE G090176) and local Institution Review Board (IRB). Study candidates must be ineligible to receive other therapies and declined heart transplantation by an experienced transplant center prior to evaluation by the study center. Acceptable, consenting patients will be enrolled in the study and implanted with a HeartMate II VAD. The primary study endpoint is 40% survival (8 of 20 patients) to 2 yrs without a disabling stroke (defined by a Modified Rankin Scale of 4 or ). Secondary endpoints include safety, functional status and quality of life assessments. A data safety monitoring plan has been developed to report adverse events and study progress to the IRB, FDA and two independent physicians. Early stopping rules are based on primary and secondary endpoints. Conclusions: The DEFINe study is approved and is now open for enrollment. The original failed Fontan patient continues to be supported at home on a VAD.