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

TransMedics11 sites in 4 countries128 target enrollmentMarch 2009

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: TransMedics
Enrollment: 128
Locations: 11
Primary Endpoint: 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

November 2013

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

TransMedics

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30

Time Frame: 30 days

Secondary Outcomes

Incidence of all cardiac graft-related serious adverse events(30 days)
Length of ICU stay(30 day)
Incidence of biopsy proven ISHLT grade 2R or 3R acute rejection on any of the surveillance endomyocardial biopsies or clinically symptomatic rejection requiring augmentation of immunosuppressive therapy during the 30 day follow up(30 day)