Study Comparing a New Temperature-Controlled System Versus Ice Storage to Reduce Heart Transplant Complications and Primary Graft Dysfunction

What this Trial Is About

Researchers are evaluating the feasibility of a new temperature control system called the Xo Port Organ Preservation System compared to the standard static ice storage for preserving donor hearts during heart transplants. This study aims to see if this novel system can reduce the occurrence of severe Primary Graft Dysfunction PGD within 24 hours after transplant and improve various composite efficacy outcomes. The trial is a randomized, blinded, controlled pilot study involving 50 patients across multiple centers over 2.5 years. Participants are randomly assigned to either the Xo Port Organ Preservation System, which maintains donor heart temperature between 8 and 12 degrees Celsius using an insulated chamber with specialized gel packs and continuous temperature monitoring, or to the standard care using ice packs for cold static storage. The trial evaluates the feasibility of this approach and protocol adherence, with possible inclusion of pilot participants in a future full-scale trial if results support it. During the study, participants complete questionnaires at screening, on transplant day day 0, and 7 and 90 days after transplant. Blood samples are taken alongside standard care blood draws immediately after transplant, the day after, and 7 days post-transplant. Researchers monitor for protocol deviations and measure the incidence of severe PGD and other composite efficacy outcomes over the 2.5-year study period to assess safety and effectiveness of the preservation methods.

Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction