Status:
RECRUITING
HOPE At Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
Lead Sponsor:
XVIVO Perfusion
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 H...
Detailed Description
This is a prospective, single-arm, multi-national, multicentre, proof-of-concept study to evaluate post-transplant outcomes after the use of direct procurement followed by a period of hypothermic oxyg...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Signed informed consent form
- Accepted and/or listed for heart transplantation
Exclusion
- 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)
Key Trial Info
Start Date :
August 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06485596
Start Date
August 3 2024
End Date
June 1 2026
Last Update
December 2 2024
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium