Heart EXPAND Continued Access Protocol

Heart Expand Continued Access Protocol

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.

Study Overview

• Status: Completed
• Conditions: Heart Transplant
• Intervention / Treatment: Device: OCS Heart System

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90211
      • Cedars-Sinai
    • Palo Alto, California, United States, 94304
      • Stanford University
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Cardiovascular Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • New York
    • New York, New York, United States, 10032
      • Nyph/Cumc
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University Of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Patient survival post transplant	30 days
Absence of severe PGD	Absence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post transplant	24 hours post heart transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Patient and graft survival	30 days
Incidence of severe PGD	Incidence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post heart transplant	24 hours post transplant
Donor heart utilization rate	The proportion of eligible donor hearts that were successfully transplanted after preservation and assessment on the OCS Heart System	24 hours post-transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Patient survival at 6 and 12 months post-transplant	6 and 12 months
Incidence of primary graft failure	Incidence of primary graft failure requiring re-transplantation	Through 12 months post transplant
ICU stay	Duration of initial post-transplant ICU stay in days	Through hospital discharge, estimated to be 14 days
Hospital stay	Duration of initial post-transplant hospital stay in days	Through hospital discharge, estimated to be 30 days

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Heart preservation; Beating heart transplant
• Other Study ID Numbers: OCS-CAR-121918

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes