OCS Heart Perfusion Post-Approval Registry

TransMedics

Status: Active, not recruiting

Conditions: Transplant

Treatments: Device: OCS Heart System

Study type: Observational

Funder types: Industry

Identifiers

NCT05047068

OCSHEART-01-ClinPAS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Recipient Exclusion Criteria:

• 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).

Trial design

350 participants in 3 patient groups

OCS DBD Heart Primary Analysis Population

Description:

200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant

Treatment:

Device: OCS Heart System

OCS DCD Heart Primary Analysis Population

Description:

150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant * Transplanted with DCD heart with 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).

Treatment:

Device: OCS Heart System

Other OCS Heart Analysis Population

Description:

Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD).

Treatment:

Device: OCS Heart System