Total Artificial Heart for Heart Failure

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: BiVACOR Inc.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Coagulopathy, Severe COPD, Diabetes, others

No Placebo Group

Approved in 1 Jurisdiction

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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Hospital Durham, NC

Banner - University Medical Center Phoenix Phoenix, AZ

The Christ Hospital Cincinnati, OH

Texas Heart Institute / Baylor St. Luke's Medical Center Houston, TX

Who Is Running the Clinical Trial?

BiVACOR Inc. Lead Sponsor

References

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

The total artificial heart for biventricular heart failure and beyond. [2012] Treatment options for late-stage biventricular heart failure are limited but include medical therapy with intravenous inotropes, biventricular assist devices (Bi-VADs) and the total artificial heart (TAH). In this manuscript, we review the indications, surgical techniques and outcomes for the TAH.

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] The aim of this study was to compare the outcomes of patients undergoing SynCardia total artificial heart (TAH) and biventricular HeartWare ventricular assist device (Bi-HVAD) support for biventricular heart failure (HF).

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] Due to the declining instances of organ donation, total artificial heart (TAH) therapy is of increasing importance for the management of end-stage biventricular heart failure. We introduce the currently most important established and novel TAH systems (SynCardia, CARMAT, ReinHeart, BiVACOR), report clinical outcomes and discuss technical requirements for the successful implementation of TAH therapy as an alternative to cardiac transplantation.

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

Clinical indications for implantation of the total artificial heart. [2014] The total artificial heart (TAH) is effective for bridging patients with biventricular heart failure (BiVHF) to transplantation. It consists of two pneumatic pumps with four mechanical valves that replace nearly the entire myocardium, thus also making it effective therapy for heart failure from alternative (ALT) anatomical and pathophysiological causes that preclude left ventricular assist device (LVAD). This report reviews the clinical indications and outcomes for TAH implantation at our institution from 2006 to 2012. We sought to characterize and compare survival to transplant for patients with BiVHF to those with ALT indications. The overall survival to transplant for all patients was 86% (57/66). There was a trend towards decreased survival to transplantation in the ALT group compared with the BiVHF group (77% vs. 93%, HR 0.42 [95% confidence interval 0.1, 1.7], log-rank test: p = 0.2). This was likely driven by certain high risk subgroups of allograft failure, LVAD failure, and acute postinfarct shock.

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

Survival after biventricular mechanical circulatory support: does the type of device matter? [2022] Biventricular support can be achieved using paracorporeal biventricular assist devices (BiVADs), the total artificial heart (TAH), and implantable VADs. This study evaluated the influence of the device on patient survival.

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

Anatomical human fitting of the BiVACOR total artificial heart. [2022] BiVACOR is a novel total artificial heart (TAH) utilizing a single centrifugal magnetically levitated rotor with the ability to modulate pulsatile flow. The device has been successfully tested in a bovine model. We undertook a multicenter anatomical and virtual fitting study of the BiVACOR in patients undergoing heart transplantation.

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

Airway Complications of Total Artificial Heart. [2020] The total artificial heart is the mechanical device which is used as a bridge to the heart transplant in patients with biventricular failure. Due to the mechanical nature of the device, patients receiving total artificial heart (TAH) require to be on anticoagulation therapy. Hemorrhage and coagulopathy are few of the known complications of TAH.

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

The total artificial heart. [2020] 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 by a pneumatically powered artificial heart. Currently, the TAH is approved for use in end-stage biventricular heart failure as a bridge to heart transplantation. However, with an increasing global burden of cardiovascular disease and congestive heart failure, the number of patients with end-stage heart failure awaiting heart transplantation now far exceeds the number of available hearts. As a result, the use of mechanical circulatory support, including the TAH and left ventricular assist device (LVAD), is growing exponentially. The LVAD is already widely used as destination therapy, and destination therapy for the TAH is under investigation. While most patients requiring mechanical circulatory support are effectively treated with LVADs, there is a subset of patients with concurrent right ventricular failure or major structural barriers to LVAD placement in whom TAH may be more appropriate. The history, indications, surgical implantation, post device management, outcomes, complications, and future direction of the TAH are discussed in this review.