Overview

This trial is active, not recruiting.

Condition heart transplant
Treatment preservation of hearts for transplantation
Phase phase 3
Sponsor TransMedics
Start date September 2015
End date October 2016
Trial size 75 participants
Trial identifier NCT02323321, OCS-CAR-012014

Summary

To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
OCS Preservation and Assessment
preservation of hearts for transplantation
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

Primary Outcomes

Measure
A composite endpoint of patient survival at Day-30 post transplant and absence of severe primary heart graft dysfunction in the first 24 hours post-transplantation
time frame: 30 Days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Registered male or female primary Heart transplant candidate - Age ≥18 years old Exclusion Criteria: - Prior solid organ or bone marrow transplant - Chronic use of hemodialysis or diagnosis of chronic renal insufficiency - Multi-organ transplant

Additional Information

Official title International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
Principal investigator Fardad Esmailian, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by TransMedics.