Clinical trial NCT05047068: OCS Heart Perfusion Post-Approval Registry
Official title: OCS Heart Perfusion (OHP) Post-Approval Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.

Brief summary: The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Detailed description: Multi-center, observational post-approval registry to:

1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.

Eligibility criteria: Inclusion Criteria:

* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.

Recipient Exclusion Criteria:

* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant.

Donor Exclusion Criteria (for DCD Donor Hearts only):

* Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).

Primary outcomes:
measure: Patient Survival
timeFrame: One year post-heart transplant
Secondary outcomes:
Other outcomes:
measure: Safety Endpoint
timeFrame: 6 months post-heart transplant
measure: Long Term Patient Survival
timeFrame: 5 years post-heart transplant
measure: Long Term Graft Survival
timeFrame: 5 years post-heart transplant
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Bronx
country: United States
facility: Montefiore
state: New York
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott and White
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin
state: Wisconsin
Study officials:
References: