OCS Heart System for Heart Transplant

(ENHANCE Trial)

Not yet recruiting at 1 trial location

Overseen By Kausar Qidwai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TransMedics

Disqualifiers: Other trials, Aortic incompetence, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-transplant period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for storing and transporting donor hearts for transplant, known as the OCS Heart system. The researchers aim to determine if this system is safer and more effective than the traditional method of keeping hearts cold in a cooler. The trial includes different groups: one uses the OCS Heart system for hearts that might not perform well with standard cold storage, and another compares it directly with cold storage for hearts that typically do well that way. Individuals who need a heart transplant and are not participating in other medical trials might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative 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 the OCS Heart System is safe for heart transplantation?

Research has shown that the OCS Heart system has been safe in previous studies. In one study, 92% of patients were alive and had no major heart problems 30 days after the procedure. The survival rate was 97% at this time, with only 6.7% experiencing serious complications. Another study found an 86% survival rate two years after the procedure when using the OCS Heart with certain donor hearts.

These results suggest that the OCS Heart is generally well-tolerated. It has been successfully used in various heart transplant situations, including with donors who don't meet the usual criteria. This background supports its safety for current trials, as it has already been tested in real-world settings with good results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OCS Heart System because it represents a novel approach to preserving donor hearts for transplantation. Unlike the traditional method of cold storage, where hearts are kept in a cold, static condition, the OCS Heart System maintains hearts in a warm, functioning state by supplying them with blood and nutrients. This dynamic preservation can potentially improve the quality and viability of donor hearts, especially those initially deemed unsuitable for transplant. By keeping hearts active and healthy until they reach the recipient, the system could help increase the number of successful heart transplants and offer hope to more patients on transplant waiting lists.

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

Research has shown that the OCS Heart System, which participants in this trial may receive, can successfully transplant donor hearts with excellent patient survival rates. In one study, 87% of donor hearts were successfully transplanted, and patients maintained high survival rates up to two years later. Another study found that 30-day survival rates exceeded 95% for both DBD and DCD donor hearts using the OCS system. The OCS Heart System also enables the use and transport of more donor hearts from greater distances without affecting early survival chances. This suggests the OCS Heart System effectively improves heart transplant outcomes. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for heart transplant donors aged 40 or older with clinically acceptable hearts, minimal coronary artery disease, and a left ventricular ejection fraction (LVEF) of 50% or less. Donors can't have severe aortic incompetence. All DCD donors must meet warm ischemic time criteria of ≤30 minutes, while DBD donor hearts should expect cross clamp times of ≥4 hours.

Inclusion Criteria

I meet the requirements to be a donor.

The donor heart I'm receiving is considered suitable for transplant.

My donor's organ was without blood flow for 30 minutes or less before preservation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive heart transplants using either the OCS Heart System or Static Cold Storage

Immediate post-transplant period

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on 30-day patient and graft survival

30 days

What Are the Treatments Tested in This Trial?

Interventions

• OCS Heart

Trial Overview The trial tests the OCS Heart System's safety and effectiveness against Static Cold Storage (SCS) in preserving donor hearts from both DBD and DCD transplants. The goal is to support FDA approval by showing that OCS may be superior to SCS in maintaining heart function after transplantation.

How Is the Trial Designed?

Group I: Part B (OCS Heart) Experimental Treatment 1 Intervention

DBD Donor Hearts Currently Used with Cold Storage

Group II: Part A (OCS Heart) Experimental Treatment 1 Intervention

DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications)

Group III: Part B (SCS) Active Control 1 Intervention

DBD Donor Hearts Currently Used with Cold Storage

Who Is Running the Clinical Trial?

TransMedics

Lead Sponsor

Trials

24

Recruited

213,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38276933/

Increasing Utilization of Extended Criteria Donor Hearts for ... Conclusions: Use of an extracorporeal perfusion system resulted in successfully transplanting 87% of donor hearts with excellent patient survival to 2 years ...

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 This project aims to evaluate outcomes between NRP and OCS transplants and how both compare to donation after brain death (DBD).

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

Increasing Utilization of Extended Criteria Donor Hearts for ... Among the initial 75 hearts transplanted in EXPAND, 88% (95% CI: 78.4%-94.4%) met the primary effectiveness outcome of patient survival at day 30 post- ...

5. journals.lww.com journals.lww.com/transplantjournal/fulltext/2022/09000/normothermic_ex_situ_heart_perfusion_with_the.16.aspx

Normothermic Ex Situ Heart Perfusion With the Organ Care... Pooled 30-d survival was 97.4% (95% confidence interval [CI], 88.5%-99.4%) for the OCS-DBD group, 96.6% (95% CI, 89.9%-98.9%) for the OCS-DCD group, and 95.7% ( ...

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/S1053249822001838

Expanding Heart Transplants from Donors After Circulatory ... The trial demonstrated that the use of OCS Heart resulted in high rate of DCD heart utilization for transplantation with excellent patient and graft survival ...