Non-Ischemic Heart Preservation for Heart Transplant

(NIHP-CAP-001 Trial)

Recruiting at 9 trial locations

Overseen By Jen Ruel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: XVIVO Perfusion

Disqualifiers: Previous transplant, Multi-organ transplant, Dialysis, Ventilator dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (day of transplant)

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to keep donor hearts healthy and safe for transplant using a device called the XVIVO Heart Assist Transport (XHAT). The goal is to determine if this method outperforms the usual heart preservation techniques. Suitable candidates for this trial include individuals already listed for a heart transplant. As an unphased trial, this study allows participants to contribute to pioneering research that could enhance heart transplant outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for heart preservation?

In earlier studies, the Non-Ischemic Heart Preservation (NIHP) method using the XVIVO Heart Assist Transport (XHAT) has shown promising safety results. Research indicates that this method, which maintains donor heart health during transport, is generally well-tolerated. One study reported no complications and excellent outcomes six months after a heart transplant using this system. These findings suggest that the technology can safely preserve hearts and might increase the number of available donors. Although encouraging, these results come from a small number of cases, so further research is needed to confirm the system's safety in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Non-Ischemic Heart Preservation (NIHP) method using the XVIVO Heart Assist Transport (XHAT) is unique because it focuses on preserving donor hearts in a non-ischemic state during transport. Unlike traditional cold storage methods, which often lead to tissue damage due to lack of oxygen, this novel approach keeps the heart in a more natural, oxygenated condition. Researchers are excited about this technique because it has the potential to improve the viability and function of transplanted hearts, possibly leading to better outcomes for heart transplant recipients. This method could extend the time a donor heart remains usable, increasing the chances for successful transplants and reducing the number of organs that go to waste.

What evidence suggests that the XVIVO Heart Preservation System is effective for heart transplantation?

Research has shown that the XVIVO Heart Assist Transport system, studied in this trial, can maintain donor hearts in good condition for transplants. This method reduces damage that occurs when blood flow returns to the heart after being stopped. One study found that heart transplants succeeded even after transporting the hearts for up to 12 hours, which is impressive. The system has also been used successfully for children's heart transplants in the U.S., demonstrating its effectiveness across different age groups. These findings suggest that this method could enhance the preservation and transport of donor hearts, increasing availability for those in need. ^{2 6 7 8 9}

Who Is on the Research Team?

Sarah Lowe

Principal Investigator

XVIVO Perfusion

Are You a Good Fit for This Trial?

This trial is for individuals listed for heart transplantation who have signed an informed consent form. It's designed to assess a new method of preserving and transporting donor hearts using the XVIVO system.

Inclusion Criteria

I have signed the consent form for the trial.

I am on the waiting list for a heart transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Preservation and transplantation of donor hearts using the XVIVO Heart Preservation System

Immediate (day of transplant)

Follow-up

Participants are monitored for safety and effectiveness after treatment

365 days

What Are the Treatments Tested in This Trial?

Interventions

• Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)

Trial Overview The study tests Non-Ischemic Heart Preservation (NIHP) with the XVIVO Heart Assist Transport (XHAT). The goal is to see if this technique safely and effectively preserves extended criteria donor hearts during transport before transplant.

How Is the Trial Designed?

Group I: Device: Preservation of hearts for transplant. Experimental Treatment 1 Intervention

Device: Preservation of hearts for transplant.

Who Is Running the Clinical Trial?

XVIVO Perfusion

Lead Sponsor

Trials

11

Recruited

1,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05881278

NCT05881278 | XVIVO Heart Perfusion System (XHPS) ... The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10759137/

Non-ischaemic preservation of the donor heart in heart ... It is hypothesised that NIHP can optimise donor heart preservation, thereby minimising ischaemia-reperfusion injury in heart transplantation, ...

3. xvivogroup.com xvivogroup.com/pressreleases/enrollment-completed-five-months-early-in-the-us-clinical-trial-evaluating-xvivos-heart-preservation-technology/

Enrollment completed five months early in the US clinical ... The PRESERVE multicenter clinical trial is intended to evaluate the safety and effectiveness of the XVIVO heart technology to support a PMA ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950133425001764

First US pediatric heart transplant using XVIVO Heart Assist ... Nonischemic organ care systems (OCS) have shown success in supporting adult donor hearts for 8+ hours, allowing for continued organ evaluation before ...

5. thelancet.com thelancet.com/journals/lancet/article/piis0140-6736(24)00258-7/fulltext

Successful heart transplant after 12 h preservation aboard ... For the first time, a heart transplant has been successfully performed after transport of a donor heart across the Atlantic Ocean, marking a ...

6. xvivogroup.com xvivogroup.com/products-services/xvivo-heart-assist-transport/

XVIVO Heart Assist Transport NIHP2019. Non-ischemic Preservation of the Donor Heart in Heart Transplantation – a Randomized, Controlled, Multicenter Trial. Registered with clinicaltrials.

7. jhltonline.org jhltonline.org/article/S1053-2498(24)00060-3/fulltext

Non-Ischemic Preservation of the Donor Heart in ... We evaluated if continuous, hypothermic, oxygenated perfusion of the donor heart with the XVIVO heart preservation technology, so called non-ischemic heart ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06895070

Study Details | NCT06895070 | XVIVO Heart Box (XHB) ... This is a continuation of the PRESERVE IDE trial to provide additional data evaluating the safety and effectiveness of the XVIVO Heart Assist Transport System.

9. jhltopen.org jhltopen.org/article/S2950-1334(25)00176-4/fulltext

First US pediatric heart transplant using XVIVO Heart Assist ... The transplant was uncomplicated, with excellent 6-month outcomes. This case highlights the potential of XHAT to expand donor access and improve ...