Donor After Circulatory Death Heart CAP Trial
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: 20-011978
NCT ID: NCT04615182
Sponsor Protocol Number: OCS-CAR-08242020
About this study
The purpose of this study is to enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance 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.
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.
Exclusion Criteria:
- Previous cardiac surgery.
- Known coronary artery disease.
- Cardiogenic shock or myocardial infarction.
- Sustained terminal EF of ≤ 50%.
- Significant valve disease except for competent bicuspid aortic valve.
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