Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07145515 · ClinicalTrials.gov registry record · NA
Enhancing Heart Allograft Function With the OCS Heart System Trial
A NA study of Heart Transplant, sponsored by TransMedics.
- Recruiting
- Registry status
- NA
- Development phase
- 655
- Enrollment target
- 8
- Study locations
NCT07145515: Recruiting NA study of Heart Transplant, sponsored by TransMedics.
NCT07145515 is a NA study of Heart Transplant that is actively recruiting participants, run by TransMedics. The registered enrollment target is 655 participants, below the 8,475-participant average among 12 other Heart Transplant trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07145515, a NA study of Heart Transplant, is actively recruiting participants, sponsored by TransMedics.
- RECRUITING
- Registry status
- NA
- Development phase
- 655 participants
- Enrollment target
- 8
- Study locations
Study Summary
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
Primary Outcome
The primary endpoint is 30-day patient and graft survival with freedom from moderate or severe LV or RV primary graft dysfunction (PGD) in the first 24 hours post-transplant.
Conditions Studied
Interventions
- DEVICE OCS Heart
- OTHER Static Cold Storage (SCS)
Study Locations (8)
New York
- Mount Sinai - New York
- Columbia University Irving Medical Center/ New York Presbyterian Hospital - New York
- Westchester Medical Center - Valhalla
California
- University of California San Francisco - San Francisco
Florida
- Tampa General Hospital - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
North Carolina
- Duke University - Durham
Texas
- Baylor Scott and White - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 655 participants |
| Start Date | 2026-01 |
| Est. Completion | 2027-07-30 |
| Phase | NA |
What NCT07145515 shows while recruiting
NCT07145515 is an interventional study that assigns participants to a tested intervention. The registered 655 participants enrollment target is mid-sized for trials with a published cap, below the 8,475-participant average among 12 other Heart Transplant trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Heart Transplant appearing as the primary indexed condition, and to 2 interventions - of which OCS Heart is the first listed.
NCT07145515 lists 8 locations in 6 states (New York, California, Florida).
Frequently Asked Questions
What is clinical trial NCT07145515 about?
NCT07145515 is a clinical study titled "Enhancing Heart Allograft Function With the OCS Heart System Trial". This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Co...
What is the current status of trial NCT07145515?
This trial is currently recruiting. It is a NA study. The enrollment target is 655 participants. The study started on 2026-01. Estimated completion is 2027-07-30.
What conditions does trial NCT07145515 study?
This clinical trial studies the following conditions: Heart Transplant.
What interventions are being tested in trial NCT07145515?
The interventions under investigation include: OCS Heart (DEVICE), Static Cold Storage (SCS) (OTHER).
Who is sponsoring clinical trial NCT07145515?
This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07145515 being conducted?
This trial has 8 study locations across California, Florida, Massachusetts, New York, North Carolina. 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 NCT07145515's enrollment target sits among peer trials
655 2nd of 12 the highest 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
-
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
RECRUITING · NA
-
XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
RECRUITING · NA
-
Heart EXPAND Continued Access Protocol
COMPLETED · NA
-
Donors After Circulatory Death Heart Trial
COMPLETED · NA
-
International EXPAND Heart Pivotal Trial
COMPLETED · NA
-
US National OCS Heart Perfusion (OHP) Registry
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05407129 · 656 participants · NA
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
- NCT06127199 · 656 participants · NA
Contraceptive Efficacy Study of Ovaprene
- NCT03671044 · 657 participants · Phase 3
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
- NCT05338697 · 657 participants
Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia