A Study to Evaluate the Effectiveness of The Portable Organ Care System (OCS™) Heart from Donors After Circulatory Death Heart
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-010243
NCT ID: NCT03831048
Sponsor Protocol Number: OCS-CAR-03202019
About this study
The purpose of this study is o evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Donor Inclusion Criteria:
- Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST).
- Donor age 18-49 years old inclusive.
- Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor.
Donor Exclusion Criteria:
- Previous cardiac surgery.
- Known coronary artery disease.
- Cardiogenic shock or myocardial infarction.
- Sustained terminal ejection fraction (EF) of ≤ 50%.
- Significant valve disease except for competent bicuspid aortic valve.
Recipient Inclusion Criteria:
- Primary heart transplant candidates.
- Age ≥ 18 years old.
- Signed:
- written informed consent document;
- authorization to use and disclose protected health information; and
- consent to TransMedics' use of recipients' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data.
Recipient Exclusion Criteria:
- Prior solid organ or bone marrow transplant.
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency.
- Multi-organ transplant.
- Investigator unwilling to randomize to either arm.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Si Pham, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available