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NCT03835754 · ClinicalTrials.gov registry record · NA
Heart EXPAND Continued Access Protocol
A NA study of Heart Transplant, sponsored by TransMedics.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 12
- Study locations
NCT03835754: Completed NA study of Heart Transplant, sponsored by TransMedics.
NCT03835754 is a NA study of Heart Transplant that has completed, run by TransMedics. The registered enrollment target is 75 participants, below the 8,524-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03835754, a NA study of Heart Transplant, has completed, sponsored by TransMedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
A composite of patient survival at Day 30 and absence of severe primary heart graft dysfunction (PGD) (LV or RV) in the first 24 hours post-transplantation according to ISHLT consensus manuscript in the protocol.
Conditions Studied
Interventions
- DEVICE OCS Heart System
Study Locations (12)
California
- Cedars-Sinai - Los Angeles
- Stanford University - Palo Alto
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- AdventHealth Orlando - Orlando
Indiana
- St. Vincent Cardiovascular Research Institute - Indianapolis
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Minneapolis Heart Institute - Minneapolis
New York
- Nyph/Cumc - New York
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2022-08-12 |
| Phase | NA |
What the finished NCT03835754 record still lists
NCT03835754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 8,524-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Heart Transplant appearing as the primary indexed condition, and to 1 intervention - of which OCS Heart System is the first listed.
NCT03835754 lists 12 locations in 11 states (California, Connecticut, Florida).
Frequently Asked Questions
What is clinical trial NCT03835754 about?
NCT03835754 is a clinical study titled "Heart EXPAND Continued Access Protocol". 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.
What is the current status of trial NCT03835754?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2019-04-17. Estimated completion is 2022-08-12.
What conditions does trial NCT03835754 study?
This clinical trial studies the following conditions: Heart Transplant.
What interventions are being tested in trial NCT03835754?
The interventions under investigation include: OCS Heart System (DEVICE).
Who is sponsoring clinical trial NCT03835754?
This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03835754 being conducted?
This trial has 12 study locations across California, Connecticut, Florida, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Transplant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03835754's enrollment target sits among peer trials
75 9th of 12 higher than 3 of 12 other Heart Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Transplant trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
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Enhancing Heart Allograft Function With the OCS Heart System Trial
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Donors After Circulatory Death Heart Trial
COMPLETED · NA
-
International EXPAND Heart Pivotal Trial
COMPLETED · NA
-
US National OCS Heart Perfusion (OHP) Registry
RECRUITING
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