OCS Heart for Heart Transplant

(OHP-II Trial)

Recruiting at 39 trial locations

Overseen By Kausar Qidwai

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: TransMedics

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

Compensation: Varies

Number of Visits: Unknown

100000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information on heart transplants where a special machine, the Organ Care System (OCS), keeps the donor heart alive. As an observational study, doctors will track the outcomes of patients who receive these specially preserved donor hearts. This trial is suitable for those who have received a heart transplant with an OCS-perfused donor heart. Participants will help researchers understand how well this method works in real-world settings. As a Phase 4 trial, this research explores how the already FDA-approved and proven effective treatment benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for the OCS Heart Transplant procedure?

Research has shown that the TransMedics Organ Care System (OCS) Heart helps keep donor hearts healthy during transport. The FDA has approved it, confirming it meets safety standards. Studies have found that using the OCS Heart does not harm early survival rates after heart transplants. In fact, hearts transported with this system show good long-term results, with a lower chance of developing CAV, a type of artery disease, compared to traditional methods.

One study found that 87% of donor hearts using the OCS system were successfully transplanted, indicating the system is generally well-tolerated. Overall, evidence suggests that the OCS Heart is safe for heart transplants and effective in preserving donor hearts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care in heart transplants, which typically involves using donor hearts preserved through cold storage, the OCS Heart Perfusion technique keeps donor hearts warm and functioning outside the body until they are transplanted. This innovative method allows for better assessment of heart health and potentially extends the time a heart remains viable for transplantation. Researchers are excited because it could increase the availability of suitable hearts and improve post-transplant outcomes, offering new hope for patients on the transplant waiting list.

What evidence suggests that the OCS Heart Transplant method is effective for heart transplant recipients?

Research has shown that the OCS Heart system aids heart transplants by enabling donor hearts to be retrieved from greater distances without affecting early survival rates. In this trial, all heart transplant recipients receiving an OCS-perfused donor heart will join the registry. Studies have found that patients receiving hearts preserved with the OCS system have similar in-hospital survival rates compared to traditional methods. Evidence also suggests that the OCS system can increase the number of available donor hearts, including those from brain-dead donors or those who died from circulatory causes. While some studies have noted differences in long-term survival, the OCS system performs well in the crucial early period after a transplant. Overall, it is a promising tool for heart transplants, particularly in expanding the availability of donor hearts. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants receive a heart transplant with an OCS-perfused donor heart

Immediate

Follow-up

Participants are monitored for safety and effectiveness after transplant

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• OCS Heart

How Is the Trial Designed?

Group I: OCS Heart Transplant Recipients Experimental Treatment 1 Intervention

All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.

Who Is Running the Clinical Trial?

TransMedics

Lead Sponsor

Trials

24

Recruited

213,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11144456/

Long-term outcomes after heart transplantation using ex ... Eight-year survival was 57.9% in the OCS group and 73.7% in the CS group (p = .24). Freedom from CAV was 89.5% in the OCS group and 67.8% in the CS group (p = .

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.073544

Paradigm Shifts in Heart Transplantation in the United States It appears that OCS facilitates greater use and more distant procurements for both DBD and DCD donors with no early survival penalty. Insights ...

3. jhltonline.org jhltonline.org/article/S1053-2498(24)00103-7/fulltext

Outcomes of DCD Heart Transplant: NRP and OCS Survival curves demonstrated significant differences (p=0.02) with lower rates of survival for OCS donors at 3 years. This difference is due to the difference ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1071916423004141

Histopathological Insights From Utilization Of Organ Care ... Both groups had a similar incidence of primary graft dysfunction (OCS n=1(10%) vs control n=3(18.7%)), p=0.55). There was 100% in-hospital survival in the OCS ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212438

Transplantation Outcomes with Donor Hearts after ... Data showing the efficacy and safety of the transplantation of hearts obtained from donors after circulatory death as compared with hearts obtained from donors ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180051S001B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The TransMedics Organ Care System (OCS) Heart is indicated for the preservation of donation-after-brain-death (DBD) hearts initially deemed ...

7. jhltonline.org jhltonline.org/article/S1053-2498(24)00365-6/fulltext

Organ Care System Heart Perfusion (OHP) Registry ... OHP registry was created to collect donor/recipient's characteristics and post-transplant outcomes for all OCS heart transplant cases in the real-world setting ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213177923008314

Increasing Utilization of Extended Criteria Donor Hearts for ... A total of 173 ECD DBD hearts were perfused; 150 (87%) were successfully transplanted; 23 (13%) did not meet study transplantation criteria.