This study is in progress, not accepting new patients

OCS Heart Perfusion Post-Approval Registry

a study on Transplants

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

OCS Heart Perfusion (OHP) Post-Approval Registry

Details

Multi-center, observational post-approval registry to:

  1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
  2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.

Keywords

Transplant, OCS Heart System, Other OCS Heart Analysis Population

Eligibility

You can join if…

Open to people ages 18 years and up

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

Recipient

You CAN'T join if...

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

Donor Exclusion Criteria (for DCD Donor Hearts only):

  • 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).

Locations

  • UCSF
    San Francisco California 94143 United States
  • Stanford University
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT05047068
Study Type
Observational [Patient Registry]
Participants
Expecting 350 study participants
Last Updated