Active — Not RecruitingNot Applicable

HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.

Belgium20 participantsStarted 2024-08-03

Plain-language summary

The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death. The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System. The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years
✓. Signed informed consent form
✓. Accepted and/or listed for heart transplantation

Exclusion criteria

✕. Not able to understand the information provided during the informed consent procedure
✕. Previous solid organ transplantation
✕. Grown-up congenital heart disease
✕. Dialysis
✕. Incompatible blood group
✕. Combined organ transplantation candidates
✕. Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
✕. Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)

What they're measuring

Patient survival

Timeframe: 30 days post-transplant

Trial details

NCT IDNCT06485596

SponsorXVIVO Perfusion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Heart Failure trials