CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
OCS Heart System +1 moredevice
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/NCT03831048
NCT03831048N/ACompleted

Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)

TransMedics·interventional·Posted Feb 5, 2019·Updated May 7, 2024

In Brief

A clinical study evaluating OCS Heart System and Cold Storage for Heart Transplant. Completed, enrolled 180 participants across 25 sites.

Detailed Summary

To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 5, 2019
Enrollment StartNov 26, 2019
Primary CompletionApr 1, 2021
Study CompletionSep 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.4 years ago

Interventions

OCS Heart Systemdevice

Preserving and assessing donor after circulatory death hearts for transplant

Cold Storageother

Active comparator intervention