Heart EXPAND CAP
Condition: Heart Transplant
Key Inclusion Criteria (Recipient)
- Registered primary heart transplant candidate
- At least 18 years old
Key Exclusion Criteria (Recipient)
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis
- Multi-organ transplant
Full Study Name
Continued Access Protocol to Collect Additional Evidence to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS) Heart for Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (Heart EXPAND CAP) (IRB no. PRO00057308)
This study focuses on individuals who have been listed to receive a heart transplant and whose doctor has determined that they may be a suitable candidate for the study. The study aims to evaluate the safety and effectiveness of the TransMedics Organ Care System (OCS) System, an experimental way to preserve, monitor and assess donor hearts during the time between removal from the donor and the patient’s transplant operation.
Traditional heart preservation methods maintain the heart in a cold, non-beating, non-oxygenated state. The OCS Heart System keeps hearts beating and warm at normal body temperature, in addition to supplying them with oxygen and nutrients throughout the preservation period. The donor heart function and condition are monitored during the preservation period so that the transplant team can assess the donor heart’s suitability for transplantation until the point the transplant procedure begins. The study will also evaluate the ability of the OCS Heart System to make more hearts available for transplantation and will monitor post-transplant clinical outcomes.