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Purpose

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

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • N/A

Exclusion Criteria

  • N/A

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
OCS Heart Transplant Recipients All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
  • Device: OCS 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington 4297983, Kentucky 6254925 40506
Contact:
Jennifer Isaacs
859-323-4738
jennifer.isaacs@uky.edu

More Details

NCT ID
NCT05915299
Status
Recruiting
Sponsor
TransMedics

Study Contact

Raicca Haqqi
9788090620
rhaqqi@transmedics.com

Detailed Description

The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US. The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.