Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	9/14/2018
Start Date:	March 2009
End Date:	November 2013

Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

The purpose of the study is to compare survival of both patients and newly transplanted
hearts following heart transplantation among patients who were transplanted with donated
hearts preserved on ice and those who were transplanted with donated hearts using the Organ
Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused
beating state. The study also compares the number of rejection episodes, heart related
adverse events, ICU time, and ventilation time between the two groups. The study is
considered a success if survival in the OCS group was not inferior to the ice group.

Inclusion Criteria:

Recipient Day of Transplant

- Registered male or female primary heart transplant candidate

- ≥18 years old

- Signed, written informed consent document and authorization to use and disclose
protected health information

Donor Hearts

- <60 years old

- Mean systolic blood pressure >60 mmHg at the time of final heart assessment

- Satisfactory echocardiography assessment defined as:

- Ejection fraction >40%

- Absence of severe segmental wall motion abnormalities

- Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall
thickness <1.3 cm)

- Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)

Exclusion Criteria:

Recipient Day of Transplant

- >4 previous sternotomies

- Chronic renal failure as defined by chronic serum creatinine >3.0 mg/dL for more than
2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for
fluid overload)

- Ventilator dependence at the time of transplant

- Use of a ventricular assist device for > 30 days and the presence of any of the
following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia

- Panel reactive antibodies > 40% with a positive prospective cross match and/or virtual
cross match

- Use of an investigational drug or device, other than OCS, during the study.

- Simultaneous transplant of non-heart allograft, except for concurrent kidney
transplant

Donor Hearts

- Abnormal coronary angiogram defined as >50% stenosis, requiring coronary bypass

- Donor-to-recipient body weight ratio of <0.6

- Inotrope support at time of final heart assessment including, but not limited to:

- Dopamine >10 ug/kg/min

- Dobutamine > 10 ug/kg/min

- Milrinone >0.3 ug/kg/min

- Epinephrine > 0.03 ug/kg/min

- Norepinephrine > 0.03 ug/kg/min

- Any bolus dose of the above prior to explants that would result in exceeding the
above stated criteria

- Presence of any exclusion criterion based on the standard practice of the
investigational site

We found this trial at

sites

Hospitalier Pitie-Salpetriere

Paris, 75013

from

Paris,