Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed informed consent document and authorization to use and disclose protected health information
• Heart transplant candidate
• Age ≥ 18 years old
Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Florida
Tampa General Hospital
RECRUITING
Tampa
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
Duke University
RECRUITING
Durham
New York
Columbia University Irving Medical Center/ New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
Mount Sinai
RECRUITING
New York
Westchester Medical Center
RECRUITING
Valhalla
Texas
Baylor Scott and White
RECRUITING
Dallas
Contact Information
Primary
Raicca Haqqi
rhaqqi@transmedics.com
978-809-0620
Backup
Kausar Qidwai
kqidwai@transmedics.com
978-494-7105
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 655
Treatments
Experimental: Part A (OCS Heart)
DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications)
Experimental: Part B (OCS Heart)
DBD Donor Hearts Currently Used with Cold Storage
Active_comparator: Part B (SCS)
DBD Donor Hearts Currently Used with Cold Storage
Related Therapeutic Areas
Sponsors
Leads: TransMedics