Heart EXPAND Continued Access Protocol

• ClinicalTrials.gov Identifier: NCT03835754
• Recruitment Status: Active, not recruiting
• First Posted: February 11, 2019
• Last Update Posted: November 8, 2021
• Sponsor: TransMedics
• Information provided by (Responsible Party): TransMedics

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

More Information

• Responsible Party: TransMedics
• ClinicalTrials.gov Identifier: NCT03835754
• Other Study ID Numbers: OCS-CAR-121918
• First Posted: February 11, 2019
• 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

Keywords provided by TransMedics:

Heart preservation; Beating heart transplant