OCS Heart Perfusion Post-Approval Registry

NCT05047068 | Active Not Recruiting FDA Device

• 1 other identifier: OCSHEART-01-ClinPAS
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 27

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.

Conditions

Transplant

Outcome Measures

Primary Outcomes (1)

• Patient Survival

  Patient survival at one-year post-heart transplant.

  One year post-heart transplant

Other Outcomes (3)

• Safety Endpoint

  6 months post-heart transplant

• Long Term Patient Survival

  5 years post-heart transplant

• Long Term Graft Survival

  5 years post-heart transplant

Study Arms (3)

OCS DBD Heart Primary Analysis Population

200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant

Device: OCS Heart System

OCS DCD Heart Primary Analysis Population

150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant * Transplanted with DCD heart with 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).

Device: OCS Heart System

Other OCS Heart Analysis Population

Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD).

Device: OCS Heart System

Interventions

OCS Heart System DEVICE

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.

OCS DBD Heart Primary Analysis Population; OCS DCD Heart Primary Analysis Population; Other OCS Heart Analysis Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• TransMedics: lead

Study Sites (27)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Montefiore

The Bronx, New York, 10467, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Baylor Scott and White

Dallas, Texas, 75226, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98105, United States

Location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 16, 2021
• Study Start: September 13, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 30, 2025

Record last verified: 2025-09

Locations

US (27)