International EXPAND Heart Pivotal Trial

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

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Key information

Conditions

Heart Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preservation of Hearts for Transplantation

Device

Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

Primary outcomes

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

A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study 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)

Acronym: EXPANDHeart

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2019
First posted: Dec 23, 2014
Registry last updated: Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed