Clinical trial NCT03835754: Heart EXPAND Continued Access Protocol
Official title: Heart Expand Continued Access Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplant
Keywords: Heart preservation
Beating heart transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Patient Survival at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Indianapolis
country: United States
facility: St. Vincent Cardiovascular Research Institute
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References: