At a glance
ClinicalIndex Comparison RecordN/ACompleted· 75 enrolled
Drug / intervention
OCS Heart Systemdevice
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.
Heart Expand Continued Access Protocol
In Brief
A clinical study evaluating OCS Heart System for Heart Transplant. Completed, enrolled 75 participants across 12 sites.
Detailed Summary
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Transplant
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartApr 2019
Primary CompletionSep 2021
Study CompletionAug 2022
TodayJul 2026
First PostedFeb 11, 2019
Enrollment StartApr 17, 2019
Primary CompletionSep 15, 2021
Study CompletionAug 12, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.4 years ago
Interventions
OCS Heart Systemdevice
The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment