Study of XVIVO Heart Assist Transport System for Preserving Extended Criteria Donor Hearts in Heart Transplantation A Multi-Center, Single-Arm Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Non-Ischemic Heart Preservation NIHP using the XVIVO Heart Preservation System XHPS to preserve and transport extended criteria donor hearts for transplantation. This continuation of the PRESERVE IDE trial aims to provide more data on the XVIVO Heart Assist Transport System XHAT while a Post-Market Approval application is under review. The study focuses on donor hearts that may not meet current standard acceptance criteria but are intended for transplantation. The trial uses the XHAT System device to preserve donor hearts through Non-Ischemic Heart Preservation. This approach is applied to hearts meeting extended criteria, such as longer cross clamp times or specific heart function measures. The study is single-arm, open-label, and prospective, allowing patients and physicians access to the device during the continued access protocol period. Participants are individuals aged 18 years or older listed for heart transplantation. Researchers will monitor patient survival rates up to one year after transplantation and treatment success at 30 days post-transplant. Assessments include clinical evaluations and safety monitoring throughout the study. The total participation duration varies depending on transplant timing and follow-up, with researchers tracking outcomes related to heart preservation and transplant success.

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)