Donor After Circulatory Death Heart CAP Trial
Trial ID or NCT#
NCT04615182
Status
RECRUITING
Purpose
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Official Title
The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - • Primary heart transplant candidates - Age ≥ 18 years old - Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' 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(s)
Yasuhiro Shudo, MD, PhD
Cardiothoracic surgeon,
Cardiac surgeon,
Cardiovascular surgeon,
Lung transplant surgeon
Clinical Assistant Professor, Cardiothoracic Surgery
Contact us to find out if this trial is right for you.
Contact
Tiffany Koyano
650-724-6921
View on ClinicalTrials.gov
