Heart EXPAND Continued Access Protocol

Heart Transplant Clinical Trial

Official title:

Heart Expand Continued Access Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835754
• Other study ID #: OCS-CAR-121918
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: August 12, 2022

Study information

• Verified date: December 2022
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 12, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Transplant

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	St. Vincent Cardiovascular Research Institute	Indianapolis	Indiana
United States	Cedars-Sinai	Los Angeles	California
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Nyph/Cumc	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

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