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Heart EXPAND Continued Access Protocol

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
Sponsor:
Information provided by (Responsible Party):
TransMedics

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
Heart Transplant Device: OCS Heart System Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Survival [ Time Frame: 30 days ]
    Patient survival post transplant

  2. 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


Secondary Outcome Measures :
  1. Survival [ Time Frame: 30 days ]
    Patient and graft survival

  2. 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

  3. 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


Other Outcome Measures:
  1. Survival [ Time Frame: 6 and 12 months ]
    Patient survival at 6 and 12 months post-transplant

  2. Incidence of primary graft failure [ Time Frame: Through 12 months post transplant ]
    Incidence of primary graft failure requiring re-transplantation

  3. ICU stay [ Time Frame: Through hospital discharge, estimated to be 14 days ]
    Duration of initial post-transplant ICU stay in days

  4. Hospital stay [ Time Frame: Through hospital discharge, estimated to be 30 days ]
    Duration of initial post-transplant hospital stay in days



Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
TransMedics
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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

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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
Keywords provided by TransMedics:
Heart preservation
Beating heart transplant