Evaluation of Safety and Effectiveness of the Paragonix™ SherpaPak Cardiac Transport System in Donation After Circulatory Death Heart Transplantation (clinicaltrials.gov Identifier: Nct05038943)

Abstract

Purpose To evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System (CTS) in the transportation of cardiac allografts recovered from donors after circulatory death (DCD) with thoracoabdominal normothermic regional perfusion (TA-NRP). Methods Institutional Review Board (IRB#0478-21-FB) approved this single center pilot study for a total number of 5 heart transplants. The study is designed as a single arm feasibility study. The study opened for enrollment on September 15th 2021, the anticipated duration is one year. All patients included in DCD NRP study (NCT04615182) will be consented to participate in DCD NRP Paragonix study (NCT05038943). Inclusion and exclusion criteria are summarized in Table 1. Donor organs will be procured after no more than 30 minutes of warm ischemia (defined as a time period commencing from systolic blood pressure < 50 mmHg to the start of reperfusion) and resuscitated in-situ with TA-NRP in accordance with the approved institutional protocol. Criteria for donor acceptance for transplantation are depicted in Table 2. Allografts will be transported from a donor site to recipient center with the SherpaPak™ CTS. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. Endpoints Primary outcome is primary graft dysfunction (PGD) at 24, 48, and 72 hours (using ISHLT definition). Secondary outcomes are: need for cardioversion or pacing to restart transplanted heart; vasoactive-inotropic score at 24, 48, and 72 hours (dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min); intensive care unit and hospital length of stay; and 30-day, 90-day, 1-year survival. To evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System (CTS) in the transportation of cardiac allografts recovered from donors after circulatory death (DCD) with thoracoabdominal normothermic regional perfusion (TA-NRP). Institutional Review Board (IRB#0478-21-FB) approved this single center pilot study for a total number of 5 heart transplants. The study is designed as a single arm feasibility study. The study opened for enrollment on September 15th 2021, the anticipated duration is one year. All patients included in DCD NRP study (NCT04615182) will be consented to participate in DCD NRP Paragonix study (NCT05038943). Inclusion and exclusion criteria are summarized in Table 1. Donor organs will be procured after no more than 30 minutes of warm ischemia (defined as a time period commencing from systolic blood pressure < 50 mmHg to the start of reperfusion) and resuscitated in-situ with TA-NRP in accordance with the approved institutional protocol. Criteria for donor acceptance for transplantation are depicted in Table 2. Allografts will be transported from a donor site to recipient center with the SherpaPak™ CTS. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. Primary outcome is primary graft dysfunction (PGD) at 24, 48, and 72 hours (using ISHLT definition). Secondary outcomes are: need for cardioversion or pacing to restart transplanted heart; vasoactive-inotropic score at 24, 48, and 72 hours (dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min); intensive care unit and hospital length of stay; and 30-day, 90-day, 1-year survival.