US National OCS Heart Perfusion (OHP) Registry

TransMedics

Status: Enrolling

Conditions: Heart Transplant

Treatments: Device: OCS Heart

Study type: Observational

Funder types: Industry

Identifiers

NCT05915299

OCS-HEART-OHP-II

Details and patient eligibility

About

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

Full 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.

Enrollment: 100,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• N/A

Exclusion criteria

• N/A

Trial design

100,000 participants in 1 patient group

OCS Heart Transplant Recipients

Description:

All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.

Treatment:

Device: OCS Heart