Heart EXPAND Continued Access Protocol
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OCS Preservation
|
Device: OCS Heart System
The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
|
Outcome Measures
Primary Outcome Measures
- Survival [30 days]
Patient survival post transplant
- Absence of severe PGD [24 hours post heart transplant]
Absence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post transplant
Secondary Outcome Measures
- Survival [30 days]
Patient and graft survival
- Incidence of severe PGD [24 hours post transplant]
Incidence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post heart transplant
- Donor heart utilization rate [24 hours post-transplant]
The proportion of eligible donor hearts that were successfully transplanted after preservation and assessment on the OCS Heart System
Other Outcome Measures
- Survival [6 and 12 months]
Patient survival at 6 and 12 months post-transplant
- Incidence of primary graft failure [Through 12 months post transplant]
Incidence of primary graft failure requiring re-transplantation
- ICU stay [Through hospital discharge, estimated to be 14 days]
Duration of initial post-transplant ICU stay in days
- Hospital stay [Through hospital discharge, estimated to be 30 days]
Duration of initial post-transplant hospital stay in days
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | St. Vincent Cardiovascular Research Institute | Indianapolis | Indiana | United States | 46260 |
| 6 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 7 | Minneapolis Heart Institute | Minneapolis | Minnesota | United States | 55407 |
| 8 | Nyph/Cumc | New York | New York | United States | 10032 |
| 9 | Duke University | Durham | North Carolina | United States | 27710 |
| 10 | Ohio State University | Columbus | Ohio | United States | 43210 |
| 11 | Vanderbilt Medical Center | Nashville | Tennessee | United States | 37232 |
| 12 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- TransMedics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OCS-CAR-121918