U.S., Aug. 29 -- ClinicalTrials.gov registry received information related to the study (NCT07145515) titled 'Enhancing Heart Allograft Function With the OCS Heart System Trial' on Aug. 25.
Brief Summary: This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
Study Start Date: Oct. 15
Study Type: INTERVENTIONAL
Condition:
Heart Transplant
Intervention:
DEVICE: OCS Heart
Preservation of donor hearts with OCS H...