OCS Heart Perfusion Post-Approval Registry

Transplant Clinical Trial

Official title:

OCS Heart Perfusion (OHP) Post-Approval Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05047068
• Other study ID #: OCSHEART-01-ClinPAS
• Status: Active, not recruiting
• Start date: September 13, 2021
• Est. completion date: December 2029

Study information

• Verified date: February 2024
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Transplant

Intervention

Device:
• OCS Heart System
The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore	Bronx	New York
United States	Northwestern Medicine	Chicago	Illinois
United States	Baylor Scott and White	Dallas	Texas
United States	Medical City Dallas	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	Cedars Sinai	Los Angeles	California
United States	Froedtert & the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Nyph/Cumc	New York	New York
United States	Stanford University	Palo Alto	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Methodist Hospital	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Westchester Medical Center	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint	Heart graft survival at 6 months post-heart transplant.	6 months post-heart transplant
Other	Long Term Patient Survival	K-M Patient survival at 1, 2, 3, 4 and 5 years post-transplant	5 years post-heart transplant
Other	Long Term Graft Survival	K-M Graft survival at 6mo, 1, 2, 3, 4 and 5 years post-transplant	5 years post-heart transplant
Primary	Patient Survival	Patient survival at one-year post-heart transplant.	One year post-heart transplant