Heart EXPAND Continued Access Protocol
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03835754 |
Recruitment Status :
Active, not recruiting
First Posted : February 11, 2019
Last Update Posted : November 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Transplant | Device: OCS Heart System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Heart Expand Continued Access Protocol |
Actual Study Start Date : | April 17, 2019 |
Actual Primary Completion Date : | September 15, 2021 |
Estimated Study Completion Date : | August 31, 2022 |

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 |
- Survival [ Time Frame: 30 days ]Patient survival post transplant
- Absence of severe PGD [ Time Frame: 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
- Survival [ Time Frame: 30 days ]Patient and graft survival
- Incidence of severe PGD [ Time Frame: 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 [ Time Frame: 24 hours post-transplant ]The proportion of eligible donor hearts that were successfully transplanted after preservation and assessment on the OCS Heart System
- Survival [ Time Frame: 6 and 12 months ]Patient survival at 6 and 12 months post-transplant
- Incidence of primary graft failure [ Time Frame: Through 12 months post transplant ]Incidence of primary graft failure requiring re-transplantation
- ICU stay [ Time Frame: Through hospital discharge, estimated to be 14 days ]Duration of initial post-transplant ICU stay in days
- Hospital stay [ Time Frame: Through hospital discharge, estimated to be 30 days ]Duration of initial post-transplant hospital stay in days

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835754
United States, California | |
Cedars-Sinai | |
Los Angeles, California, United States, 90211 | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
United States, Connecticut | |
Yale New Haven Hospital | |
New Haven, Connecticut, United States, 06510 | |
United States, Florida | |
AdventHealth Orlando | |
Orlando, Florida, United States, 32803 | |
United States, Indiana | |
St. Vincent Cardiovascular Research Institute | |
Indianapolis, Indiana, United States, 46260 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Minneapolis Heart Institute | |
Minneapolis, Minnesota, United States, 55407 | |
United States, New York | |
Nyph/Cumc | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Tennessee | |
Vanderbilt Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195 |
Responsible Party: | TransMedics |
ClinicalTrials.gov Identifier: | NCT03835754 |
Other Study ID Numbers: |
OCS-CAR-121918 |
First Posted: | February 11, 2019 Key Record Dates |
Last Update Posted: | November 8, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Heart preservation Beating heart transplant |