Actively Recruiting
Enhancing Heart Allograft Function With the OCS Heart System Trial
Led by TransMedics · Updated on 2026-01-12
655
Participants Needed
8
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Enhancing Heart Allograft Function With the OCS Heart System Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Donor hearts deemed clinically acceptable for transplantation after physical examination
- All DCD donors with functional warm ischemic time ≤ 30 minutes
- DBD donor hearts with expected cross clamp time ≥ 4 hours or with specified organ quality concerns
- Eligible DBD donor hearts with expected cross clamp time < 4 hours for randomization to treatment arms
- Signed informed consent and authorization to use protected health information
- Heart transplant candidate
- Age 18 years or older
You will not qualify if you...
- Moderate to severe aortic incompetence in donor hearts
- DBD donors with organ quality concerns including donor age ≥ 40 years, unknown downtime, insignificant coronary artery disease, or left ventricular ejection fraction ≤ 50%
- Participants involved in other interventional clinical trials that may affect outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, United States, 10032
Not Yet Recruiting
6
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
7
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Baylor Scott and White
Dallas, Texas, United States, 75226
Actively Recruiting
Research Team
R
Raicca Haqqi
CONTACT
K
Kausar Qidwai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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