VitaSmart HOPE System: Bridge to HOPE Registry

Bridge to Life

Status: Invitation-only

Conditions: Liver Failure; End Stage Liver DIsease

Treatments: Device: hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions

Study type: Observational

Funder types: Industry

Identifiers

NCT07578441

HOPE-2026-01

Details and patient eligibility

About

This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions. Clinical data from up to 5000 transplant recipients will be included in the registry at up to 20 U.S. transplant centers. This registry will include clinical data collected retrospectively from medical records of recipients already transplanted before the initiation of the registry and any new recipients of livers that meet donor selection criteria. This registry introduces no contact with the transplant recipient and registry participants will follow standard of care. Data will be collected through up to 5 years of standard of care clinical follow-up.

This registry represents minimal risk to the transplant recipients being studied. The participants included in this registry will have undergone transplant surgery with a deceased donor liver graft that was perfused using the VitaSmart HOPE System, a medical device that is cleared by the Food and Drug Administration (FDA) for commercial use in the U.S. All perfusions of deceased donor liver grafts will be performed in accordance with standard medical practice.

The objectives of this registry is to Evaluate the safety and efficacy of HOPE prior to liver transplantation in real-world clinical settings.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Liver graft accepted for transplant and perfused using the VitaSmart HOPE System

Exclusion criteria

1. Liver from a living donor
2. Split liver transplant

Trial design

5,000 participants in 1 patient group

Patients undergoing liver transplantation with a donor graft that was perfused using VitaSmart

Description:

Recipients who received a deceased donor liver graft that was perfused using VitaSmart hypothermic oxygenated perfusion therapy.

Treatment:

Device: hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions