Primary objective:To evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.Secondary objective(s):The secondary objectives are to evaluate…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined as patient survival at 30 days post-transplant.
Secondary outcome
Secondary endpoints at 30-days post-transplant
1. Cardiac related mortality at 30 days post-transplant
2. Incidence of Mechanical circulatory support within 30 days post-transplant
3. Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours
post-transplant (Kobashigawa et al., 2014)
4. Cardiac function as assessed by left ventricular ejection fraction (LVEF) at
24 hours and 30 days post-transplant
5. Incidence of hearts perfused on the investigational device which are not
used for transplantation
6. Total duration of ICU stay (days)
7. Incidence of biopsy proven rejections > 1 ACR (leading to changed
immunosuppressive regime) within 30 days post-transplant
Secondary endpoints at 6 months post-transplant
8. Cardiac related mortality at 6 months post -transplant
9. Cardiac function as assessed by left ventricular ejection fraction (LVEF) at
6 months post-transplant
10. Number of days until hospital discharge from index procedure
11. Incidence of biopsy proven rejections > 1 ACR leading to changed
immunosuppressive regime within 6 months post-transplant
Exploratory endpoints
12. Cardiac biopsy collected before reperfusion (optional and only if in
clinical routine)
Background summary
Study rationale:
Clinical investigation to support the use of direct procurement (DP) of donor
hearts in donation after circulatory death (DCD) followed by hypothermic
oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby
increasing the utilization of DCD donor hearts heart in donation after
circulatory death.
Hypothesis:
The hypothesis is that the use of DP-HOPE in DCD heart transplantation is safe
and feasible.
Study objective
Primary objective:
To evaluate patient survival after direct procurement and hypothermic
oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist
Transport System.
Secondary objective(s):
The secondary objectives are to evaluate patient outcomes and graft function
post-transplant.
Study design
Prospective, single-arm, multicentre, multinational proof-of-concept study.
Intervention
Heart transplantation.
Study burden and risks
There are no extra interventions (apart from the use of the XVIVO Heart Assist
Transport System for donor heart procurement) associated with participation in
the study. All clinical procedures are performed according to standard clinical
care at the participating sites and the medical needs of each subject. There
are no extra interventions for the study subjects.
A patient receiving a donor heart perfused with XVIVO Heart Assist Transport
System may experience the same kind of adverse events and post-transplant
complications as those experienced with any heart transplant. The following
clinically relevant residual risks have been identified:
• Systemic infection
• Irreversible injury to the donor heart, heart not transplanted.
• Injury to the donor heart - Heart transplanted (Reversible, e.g. mild PGD;
Moderate, e.g. temporarily reduced cardiac function, cardiac
arrythmia, cardiac tamponade, moderate PGD, allograft rejection; or
Major injury, e.g. cardiac arrest, myocardial infarction, severe PGD,
ventricular fibrillation, aortic injury, multiorgan failure, septic
shock)
• Anaphylactic, allergic or toxic reactions
While these risks have been identified as associated with the XVIVO Heart
Assist Transport system, the same severe risks are associated with heart
transplantation in general, regardless of the method used to preserve the donor
heart. This includes *systemic infection* and *injury to the donor heart*,
since any invasive procedure carries a risk of infection, and there is always a
risk of receiving a heart that does not function properly after transplantation.
The residual risk of anaphylactic, allergic or toxic reactions is related to
components of the solution (i.e. Human serum albumin (HSA) and dextran). During
heart transplantation the patient is under extensive monitoring in an operating
room. In the unlikely event of an anaphylactic reaction this would be noted
instantly and the patient would be treated immediately under extensive
surveillance. When administered systemically, HSA has been associated with rare
allergic reactions (<1 in 1000) such as urticaria, fever, chills, pruritus and
anaphylaxis. Dextran has also been associated with rare anaphylactic reactions
(<1 in 1000); however, no such reactions have been reported with either of
these substances when used for ex vivo organ perfusion/preservation and
subsequently transplanted. Interactions with concomitant medication
There are no known interactions with concomitant medication.
The risks related to the use of the XVIVO Heart Assist Transport System are
weighed against the benefit of facilitating DCD heart procurement and
increasing the donor pool. The benefit of increasing the number of donor hearts
available without compromising the patient outcomes ultimately reduces waitlist
mortality. When weighed together, a positive benefit/risk ratio of the XVIVO
Heart Assist Transport System has been demonstrated.
Gemenskapens gata 9
Mölndal 43153
NL
Gemenskapens gata 9
Mölndal 43153
NL
Listed location countries
Age
Inclusion criteria
Inclusion - Heart donor
1. Accepted as a heart donor by the transplant team based on current standard
of care criteria
2. DCD Maastricht category III and euthanasia donors
3. Age <= 60 years old
Inclusion Recipient
1. Age >=18 years
2. Signed informed consent form
3. Accepted or listed for heart transplantation
Exclusion criteria
Exclusion - Heart Donor
1. Functional warm ischemia time (FWIT) > 30 minutes.
2. Donor cardiac arrest does not occur within 120 minutes from Withdrawal of
life sustaining therapy (WLST)
3. Deviations from Donor end of life treatment protocol as defined by local
standard operating procedures
4. Donor heart assessed as not transplantable by the responsible clinician at
any time point during the donation or procurement procedure
Exclusion Recipient
1. Not able to understand the information provided during the informed consent
procedure
2. Previous solid organ transplantation
3. Grown-up congenital heart disease (GUCH)
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 at time of transplantation (except durable
Left ventricular assist device or Intra-aortic balloon pump)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86559.000.24 |
| Other | Not available yet |