Heart EXPAND Continued Access Protocol
Heart Expand Continued Access Protocol
1 other identifier
interventional
75
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
April 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2022
CompletedResults Posted
Study results publicly available
January 17, 2025
CompletedJanuary 17, 2025
December 1, 2022
2.4 years
January 22, 2019
December 23, 2024
December 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Survival at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation
A composite of patient survival at Day 30 and absence of severe primary heart graft dysfunction (PGD) (LV or RV) in the first 24 hours post-transplantation according to ISHLT consensus manuscript in the protocol.
30 days
Study Arms (1)
OCS Preservation
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (12)
Cedars-Sinai
Los Angeles, California, 90211, United States
Stanford University
Palo Alto, California, 94304, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Nyph/Cumc
New York, New York, 10032, United States
Duke University
Durham, North Carolina, 27710, United States
Ohio State University
Columbus, Ohio, 43210, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (1)
Schroder JN, Patel CB, DeVore AD, Casalinova S, Koomalsingh KJ, Shah AS, Anyanwu AC, D'Alessandro DA, Mudy K, Sun B, Strueber M, Khaghani A, Shudo Y, Esmailian F, Liao K, Pagani FD, Silvestry S, Wang IW, Salerno CT, Absi TS, Madsen JC, Mancini D, Fiedler AG, Milano CA, Smith JW. Increasing Utilization of Extended Criteria Donor Hearts for Transplantation: The OCS Heart EXPAND Trial. JACC Heart Fail. 2024 Mar;12(3):438-447. doi: 10.1016/j.jchf.2023.11.015. Epub 2024 Jan 24.
PMID: 38276933DERIVED
Results Point of Contact
- Title
- Laura Damme
- Organization
- TransMedics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2019
First Posted
February 11, 2019
Study Start
April 17, 2019
Primary Completion
September 15, 2021
Study Completion
August 12, 2022
Last Updated
January 17, 2025
Results First Posted
January 17, 2025
Record last verified: 2022-12