Sponsor-Initiated OCS Heart Perfusion Registry (OHP-II)

February 29, 2024 updated by: TransMedics

Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Yasuhiro Shudo, MD, PhD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Liviu Klein, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Lucian Lozonschi, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Mani Daneshmand, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Christopher Salerno, MD
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky
        • Contact:
          • Jennifer Isaacs
        • Principal Investigator:
          • Rajasekhar Malyala, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • David D'Alessandro, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Masash Kai, MD
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Corina Ghita
        • Principal Investigator:
          • Jonathan Haft, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford
        • Principal Investigator:
          • Celeste Williams, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
        • Principal Investigator:
          • Benjamin Sun, MD
        • Contact:
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Andrew Shaffer, MD
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
          • Deborah Rolbiecki
        • Principal Investigator:
          • Mauricio Villavicencio, MD
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore
        • Contact:
        • Principal Investigator:
          • Daniel Goldstein, MD
      • New York, New York, United States, 10032
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Chapel Hill, North Carolina, United States, 48109
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • John Ikonomidis, MD
      • Charlotte, North Carolina, United States, 28203
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Jacob Schroder, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Arman Kilic, MD
    • Texas
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott and White
        • Principal Investigator:
          • Dan Meyer, MD
        • Contact:
          • Lesia Parker
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • University of Washington Medical Center
        • Contact:
        • Principal Investigator:
          • Jay Pal, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert & the Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Lucian Durham, MD
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St Luke's Medical Center
        • Principal Investigator:
          • Nasir Sulemanjee, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • N/A

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OCS Heart Transplant Recipients
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient survival
Time Frame: One year post-heart transplant
Patient survival at one-year post-heart transplant.
One year post-heart transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TransMedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2033

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • OCS-HEART-OHP-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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