This is a prospective, multicenter trial with a primary endpoint of patient & graft survival at day 30 post-transplant and freedom from moderate or severe left or right ventricle primary graft dysfunction (PGD) within the initial 24 hours post-transplantation. 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.
ENHANCE
Enhancing Heart Allograft Function with the OCS Heart System (ENHANCE) Trial
Heart failure, Heart transplantation
All genders
18+
Recruiting now
Overview
Principal Investigator: Gregory Couper, MD
Contact Us
Gaurav Das/Abena Adwetewa-Badu (Abena.Adwetewa-Badu@tuftsmedicine.org)
Study details
Inclusion Criteria
- Signed informed consent document and authorization to use and disclose protected health information
- Heart transplant candidate
- Age ≥ 18 years old
Exclusion Criteria
- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
Study Requirements
If you get a heart transplant in this study, your data will be collected through 6-months after your transplant. The sponsor of the study may access the national transplantation database to follow your progress through up to 5-years after your transplant. There is no additional testing, or blood collection for the study.