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

Trial Summary

What is the purpose of this trial?

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 biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects.

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 data supports the effectiveness of the BiVACOR Total Artificial Heart treatment for heart failure?

The BiVACOR Total Artificial Heart is part of a group of total artificial heart systems that have shown effectiveness in managing end-stage biventricular heart failure, especially when heart transplants are not available. Studies on similar systems have reported high survival rates to transplantation, indicating their potential effectiveness in supporting patients with severe heart failure. ^{1 2 3 4 5}

What makes the BiVACOR Total Artificial Heart treatment unique for heart failure?

The BiVACOR Total Artificial Heart is unique because it uses a single centrifugal magnetically levitated rotor to modulate blood flow, which is different from other artificial hearts that may use different mechanisms. This novel design allows it to replace the entire heart, providing a full mechanical circulatory support for patients with severe heart failure, especially when heart transplants are not available. ^{1 3 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The total artificial heart for biventricular heart failure and beyond. [2012]

2. China 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. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Current state of total artificial heart therapy and introduction of the most important total artificial heart systems. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical indications for implantation of the total artificial heart. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Survival after biventricular mechanical circulatory support: does the type of device matter? [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Anatomical human fitting of the BiVACOR total artificial heart. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Airway Complications of Total Artificial Heart. [2020]

8. China pubmed.ncbi.nlm.nih.gov

The total artificial heart. [2020]