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

TransMedics

Status

Completed

Conditions

Heart Failure

Treatments

Device: Organ Care System

Device: Cold Cardioplegia Solution

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00855712

CAR-05-2008

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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