Status:
COMPLETED
Heart EXPAND Continued Access Protocol
Lead Sponsor:
TransMedics
Conditions:
Heart Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
Detailed Description
To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as id...
Eligibility Criteria
Inclusion
- Inclusion Criteria (DONOR):
- At least one of the following:
- Expected total cross-clamp time of ≥ 4 hours
- Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of \>12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.
- Exclusion
- CAD with \> 50% stenosis on angiogram, or
- Cardiogenic shock or myocardial infarction, or
- EF consistently \< 40%, or
- Significant valve disease except for competent bicuspid aortic valve.
- Eligibility Criteria (RECIPIENT)
- Registered primary heart transplant candidate
- Age \>18 years old
- Written informed consent. Exclusion
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis
- Multi-organ transplant.
Exclusion
Key Trial Info
Start Date :
April 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03835754
Start Date
April 17 2019
End Date
August 12 2022
Last Update
January 17 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai
Los Angeles, California, United States, 90211
2
Stanford University
Palo Alto, California, United States, 94304
3
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
4
AdventHealth Orlando
Orlando, Florida, United States, 32803