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Heart EXPAND Continued Access Protocol

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ClinicalTrials.gov Identifier: NCT03835754
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : July 26, 2019
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)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heart Expand Continued Access Protocol
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 31, 2020

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



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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
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Yasuhiro Shudo, MD, PhD    650-725-5895    yshudo@stanford.edu   
Principal Investigator: Yasuhiro Shudo, MD, PhD         
United States, Florida
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Christine Singleton, RN    407-303-7120    mailto:Christine.Singleton@AdventHealth.com   
Principal Investigator: Scott Silvestry, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: David A D'Alessandro, MD    617-726-8842    dadalessandro@mgh.harvard.edu   
Principal Investigator: David A D'Alessandro, MD         
United States, Minnesota
Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Karl Thomas    612-863-7493    karl.m.thomas@allina.com   
Principal Investigator: Karol Mudy, MD         
United States, New York
Columbia Presbyterian Recruiting
New York, New York, United States, 10032
Contact: Michelle Yuan    212-305-3009    my2573@cumc.columbia.edu   
Principal Investigator: Yoshifumi Naka, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Jacob N Schroder, MD    919-681-7862    jacob.schroder@duke.edu   
Principal Investigator: Jacob Schroder, MD         
United States, Tennessee
Vanderbilt Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Lisa Slinger    615-875-2602    lisa.slinger@vumc.org   
Principal Investigator: Ashish Shah, MD         
Sponsors and Collaborators
TransMedics

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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT03835754     History of Changes
Other Study ID Numbers: OCS-CAR-XXXX
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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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