Total Artificial Heart for Heart Failure

Recruiting at 3 trial locations

Overseen By Diane Covington

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BiVACOR Inc.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Coagulopathy, Severe COPD, Diabetes, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the BiVACOR Total Artificial Heart (TAH) System can extend the lives of people with severe heart failure while they await a heart transplant. It focuses on individuals with biventricular heart failure or those unable to use a left-side support device. The study will assess the safety and effectiveness of the BiVACOR TAH for these patients. It seeks participants with serious, ongoing heart issues who do not respond to current treatments but qualify for a heart transplant. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance future heart failure treatments.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BiVACOR Total Artificial Heart is safe for patients with severe heart failure?

Research shows that the BiVACOR Total Artificial Heart (TAH) System could benefit patients with severe heart failure. Studies indicate that this device assists patients awaiting a heart transplant.

Early results suggest that most patients handle the BiVACOR TAH well. These initial studies examine the device's safety and effectiveness in helping patients survive until they receive a new heart. Although still under testing, no major safety issues have been reported so far.

Patients in early trials have used the device successfully, indicating it might serve as a good temporary heart support option. As with any medical treatment, discussing potential risks and benefits with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BiVACOR Total Artificial Heart (TAH) system is unique because it offers a novel solution for patients with severe biventricular heart failure who can't benefit from conventional treatments like Left Ventricular Assist Devices (LVADs). Unlike most heart failure treatments that rely on supporting or replacing just one side of the heart, the BiVACOR TAH is designed to fully replace both ventricles, providing a complete heart function in one device. Its innovative rotary pump technology mimics the natural heart's blood flow more closely than traditional mechanical hearts, potentially improving outcomes and quality of life for patients awaiting heart transplants. Researchers are excited about this system as it represents a significant advancement in bridging therapy, offering hope to those with limited options.

What evidence suggests that the BiVACOR TAH System is effective for heart failure?

Research has shown that the BiVACOR Total Artificial Heart (TAH) System holds promise for patients with severe heart failure. One study demonstrated that five patients with severe heart problems received the BiVACOR TAH and successfully underwent heart transplants afterward. This suggests that the BiVACOR TAH can effectively support patients until they receive a heart transplant. In this trial, participants will receive the BiVACOR TAH, which replaces the failing parts of the heart and provides the mechanical support needed to sustain life. This system is designed for patients who cannot benefit from other devices and require new options for heart support. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with severe heart failure who need mechanical support to survive and are waiting for a heart transplant. They must have specific heart function measurements like low right ventricular ejection fraction or high central venous pressure, indicating advanced heart issues.

Inclusion Criteria

The ratio of CVP to PCWP is higher than 0.63.

Your right ventricular stroke work index is less than or equal to 0.25 g/m/beat/m2.

Your pulmonary artery pressure index is less than 2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Monitoring

The BiVACOR TAH System is implanted as a bridge to transplant for eligible patients, followed by initial monitoring for safety and performance

6 months or until heart transplant

Follow-up

Participants are monitored for safety and effectiveness after the initial implantation and monitoring phase

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BiVACOR TAH System

Trial Overview The study tests the BiVACOR Total Artificial Heart (TAH) System as a temporary solution for patients with severe biventricular or univentricular heart failure until they can get a transplant. It checks if the device is safe and works well in supporting their circulatory system.

How Is the Trial Designed?

Group I: BiVACOR TAH Experimental Treatment 1 Intervention

The BiVACOR TAH System will be implanted as a bridge to transplant (BTT) for adults with severe irreversible biventricular heart failure or univentricular heart failure in which LVAD support is not recommended, and who are eligible for cardiac transplantation.

BiVACOR TAH System is already approved in United States for the following indications:

Approved in United States as BiVACOR TAH for:

• Severe biventricular heart failure
• Univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended

Who Is Running the Clinical Trial?

BiVACOR Inc.

Lead Sponsor

Trials

1

Recruited

5+

Published Research Related to This Trial

Total artificial heart (TAH) therapy is becoming increasingly important for treating end-stage biventricular heart failure due to a decline in organ donations.

The review discusses established and novel TAH systems, including SynCardia and CARMAT, and highlights their clinical outcomes and technical requirements for successful implementation as alternatives to heart transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state of total artificial heart therapy and introduction of the most important total artificial heart systems. Spiliopoulos, S., Hergesell, V., Wasler, A., et al.[2019]

The Total Artificial Heart (TAH) provides complete biventricular replacement, eliminating the need for postoperative inotropes and reducing complications related to cannulae, which is a significant advantage over biventricular assist devices (Bi-VADs).

Patients with the TAH can begin rehabilitation early after surgery, and the development of a portable drive may allow for quicker hospital discharge, making it a promising option for those with advanced heart failure who cannot use traditional assist devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The total artificial heart for biventricular heart failure and beyond. Kasirajan, V., Tang, DG., Katlaps, GJ., et al.[2012]

In a study of 383 patients receiving biventricular support, survival rates while on support and after heart transplantation were similar across different devices (paracorporeal BiVADs, implantable BiVADs, and total artificial heart).

Patients supported with the total artificial heart (TAH) showed a significantly lower stroke rate and a trend toward improved survival during prolonged support (≥90 days), suggesting potential advantages in neurological safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival after biventricular mechanical circulatory support: does the type of device matter? Kirsch, M., Mazzucotelli, JP., Roussel, JC., et al.[2022]

The total artificial heart (TAH) is a mechanical device that replaces both ventricles and valves in patients with end-stage biventricular heart failure, serving as a bridge to heart transplantation.

As the demand for heart transplants exceeds supply, the TAH is becoming increasingly important, especially for patients who cannot be treated effectively with left ventricular assist devices (LVADs) due to right ventricular failure or other complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The total artificial heart. Cook, JA., Shah, KB., Quader, MA., et al.[2020]

Patients supported by the Bi-HVAD were significantly more likely to be discharged home on support (73%) compared to those with the SynCardia TAH (6%), indicating a better option for long-term management of biventricular heart failure.

Both groups had similar overall mortality rates at a mean follow-up of 120 days, but patients with Bi-HVAD support experienced a longer duration of support (167 days) compared to those with TAH (71 days), suggesting that Bi-HVAD may provide a more sustainable solution for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of SynCardia total artificial heart and HeartWare HVAD biventricular support for management of biventricular heart failure: a systematic review and meta-analysis. Maynes, EJ., O'Malley, TJ., Luc, JGY., et al.[2023]

The total artificial heart (TAH) is an effective option for patients with biventricular heart failure (BiVHF), achieving an overall survival to transplant rate of 86% based on data from 66 patients between 2006 and 2012.

Patients with alternative (ALT) indications for TAH showed a trend towards lower survival to transplant (77%) compared to those with BiVHF (93%), suggesting that certain high-risk subgroups may impact outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical indications for implantation of the total artificial heart. Thanavaro, KL., Tang, DG., Kasirajan, V., et al.[2014]

The total artificial heart (TAH) serves as a temporary solution for patients with biventricular failure while they await a heart transplant, highlighting its role in critical care.

Patients with a TAH must undergo anticoagulation therapy to prevent complications such as hemorrhage and coagulopathy, which are common risks associated with the mechanical nature of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway Complications of Total Artificial Heart. Pathak, V., Donovan, C., Malhotra, R.[2020]

The BiVACOR total artificial heart (TAH) was successfully tested in 10 patients undergoing heart transplantation, demonstrating a suitable fit in all cases without distorting the surrounding anatomy.

This study indicates that the BiVACOR TAH can accommodate a variety of body types and heart failure causes, suggesting its potential for broad applicability in heart transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical human fitting of the BiVACOR total artificial heart. Emmanuel, S., Jansz, P., McGiffin, D., et al.[2022]

Citations

1. bivacor.com bivacor.com/

BiVACOR, Inc. – Replacing Hearts. Restoring Lives. Implantation of a Total Artificial Heart (TAH) is a treatment option for patients with end-stage biventricular HF who need support while on a heart transplant ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4703693/

The total artificial heart - PMC - PubMed Central - NIH The total artificial heart (TAH) is a form of mechanical circulatory support in which the patient's native ventricles and valves are explanted and replaced

3. link.springer.com link.springer.com/rwe/10.1007/978-3-031-09048-6_14

BiVACOR Total Artificial Heart and Future Concepts The BiVACOR Total Artificial Heart (TAH) System is designed as a short- and long-term implantable replacement option for the failing human ...

4. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/bivacor-total-artificial-heart-implanted-in-five-patients/

Bivacor Total Artificial Heart Implanted in Five Patients Five patients with severe biventricular failure received the BiVACOR TAH as a bridge to heart transplant, with all five successfully receiving transplants and ...

5. trial.medpath.com trial.medpath.com/clinical-trial/b42f9127cb1d82de/nct06174103-bivacor-total-artificial-heart-feasibility-study

BiVACOR® Total Artificial Heart Early Feasibility Study The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe ...

6. jhltonline.org jhltonline.org/article/S1053-2498(25)00238-4/fulltext

Initial Clinical Experience with the BiVACOR Total Artificial ... The BiVACOR total artificial heart (TAH) is a novel centrifugal flow device intended to support patients with end-stage biventricular heart failure (HF)

7. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624001379505

BiVACOR® Total Artificial Heart Clinical Feasibility Study ... The BiVACOR TAH System will be used as a bridge to transplant (BTT) for adults with severe irreversible biventricular heart failure or ...

8. bivacor.com bivacor.com/the-texas-heart-institute-implants-bivacor-total-artificial-heart/

The Texas Heart Institute Implants BiVACOR® Total ... The first-in-human clinical study aims to evaluate the safety and performance of the BiVACOR TAH as a bridge-to-transplant solution for patients ...