HOPE At Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
NCT ID: NCT06485596
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-08-03
2026-06-30
Brief Summary
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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.
Detailed Description
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The investigation will be conducted at 4 heart transplant centres, one in Belgium and three in The Netherlands.The study will include 20 DCD heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications, patient survival and graft function for a period of 6 months post-transplant.
The study will not include a control group as this is a proof-of-concept study, investigating an alternative method of procurement of DCD hearts by providing additional safety and performance data.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCD Direct procurement
Direct procurement of DCD donor hearts
XVIVO Heart Assist Transport System
Direct procurement of donor hearts from DCD donation
Interventions
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XVIVO Heart Assist Transport System
Direct procurement of donor hearts from DCD donation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent form
3. Accepted and/or listed for heart transplantation
Exclusion Criteria
2. Previous solid organ transplantation
3. Grown-up congenital heart disease
4. Dialysis
5. Incompatible blood group
6. Combined organ transplantation candidates
7. Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
8. Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)
18 Years
ALL
No
Sponsors
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XVIVO Perfusion
INDUSTRY
Responsible Party
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Principal Investigators
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Filip Rega, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Filip Rega, Professor
Role: primary
Other Identifiers
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HOPE at Heart
Identifier Type: -
Identifier Source: org_study_id