International EXPAND Heart Pivotal Trial

TransMedics75 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Transplant

Interventions

Preservation of Hearts for TransplantationDEVICE

Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Indiana University

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation

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.

Time frame: 30 Days

Data from ClinicalTrials.gov

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