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NCT05915299 Clinical Trial

Sponsor-Initiated OCS Heart Perfusion Registry

Heart Transplant Clinical Trial

— OHP-II  

Official title:
Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05915299
Other study ID # OCS-HEART-OHP-II
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 25, 2023
Est. completion date August 31, 2033

Study information
Verified date February 2024
Source TransMedics
Contact Raicca Haqqi
Phone 9788090620
Email rhaqqi@transmedics.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.

Description:

The objective of this sponsor-initiated OHP-II Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and document the performance of the OCS device in the real-world setting. All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled. All interested U.S. Heart transplant centers that use the OCS Heart System for donor heart perfusion will constitute the OHP-II Registry participating centers.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date August 31, 2033
Est. primary completion date August 31, 2029
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - N/A Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OCS Heart
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 Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Montefiore Bronx New York
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Atrium Health Charlotte North Carolina
United States University of Chicago Chicago Illinois
United States Baylor Scott and White Dallas Texas
United States Henry Ford Detroit Michigan
United States Duke University Durham North Carolina
United States Mayo Clinic Florida Jacksonville Florida
United States University of Kentucky Lexington Kentucky
United States Aurora St Luke's Medical Center Milwaukee Wisconsin
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 Nyph/Cumc New York New York
United States Stanford University Palo Alto California
United States Mayo Clinic Rochester Rochester Minnesota
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
Primary Patient survival Patient survival at one-year post-heart transplant. One year post-heart transplant
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