RecruitingNCT05915299

US National OCS Heart Perfusion (OHP) Registry

Sponsor

TransMedics

Enrollment

100,000 participants

Start Date

Aug 25, 2023

Study Type

OBSERVATIONAL

Conditions

Heart Transplant

Summary

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

Eligibility

Inclusion Criteria1

Exclusion Criteria1

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Interventions

DEVICEOCS Heart

The TransMedics® Organ Care System (OCS) Heart System is an FDA approved portable extracorporeal heart perfusion and monitoring system. 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(37)

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

University of California San Diego

La Jolla, California, United States

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Stanford University

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

Boulder

Boulder, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford

Detroit, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Mount Sinai

New York, New York, United States

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, United States

Montefiore

The Bronx, New York, United States

Westchester Medical Center

Valhalla, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Atrium Health

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor Scott and White

Dallas, Texas, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University Health

Richmond, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, United States

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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