CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Preservation of Hearts for Transplantationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02323321
NCT02323321N/ACompleted

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)

TransMedics·interventional·Posted Dec 23, 2014·Updated Jan 17, 2025

In Brief

A clinical study evaluating Preservation of Hearts for Transplantation for Heart Transplant. Completed, enrolled 75 participants across 11 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 23, 2014
Enrollment StartSep 16, 2015
Primary CompletionApr 25, 2018
Study CompletionMar 2, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.5 years ago

Interventions

Preservation of Hearts for Transplantationdevice

Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation