Heart FailureNCT06174103
BiVACOR® Total Artificial Heart Early Feasibility Study
A study testing BiVACOR TAH System in people with Heart Failure and Biventricular Failure, run by BiVACOR Inc. at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure, Biventricular Failure
- What is being tested?
- BiVACOR TAH System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jun 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines or has univentricular heart failure in which LVAD support is not recommended. ISHLT Guidelines for Biventricular Support:
- Biventricular failure with at least two of the following hemodynamic and/or echocardiographic measurements.
- Right ventricular ejection fraction (RVEF) ≤ 30%
- Right ventricular stroke work index (RVSWI) ≤ 0.25 g/m/beat/m2
- Tricuspid annular plane systolic excursion (TAPSE) ≤ 14 mm
- Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio > 0.72
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- Central venous pressure (CVP) > 15mmHg
- CVP to pulmonary capillary wedge pressure (PCWP) ratio > 0.63
- Tricuspid insufficiency grade 4
- Pulmonary artery pressure index (PAPi) < 2
- Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
- Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative heart disease).
- Patient is categorized as INTERMACS Patient Profile Classification 2 or 3.
- Patient is classified as NYHA Class IV.
- Patient has a left ventricular ejection fraction (LVEF) ≤ 25%, with the exception of patients with restrictive or constrictive physiology.
- Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 L/min/m2 without inotropes if inotropes are contraindicated (e.g., restrictive or constrictive heart failure), and meets one of the following criteria:
- Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or
- Has advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support device (MCSD) for at least seven days.
- Patient is eligible for cardiac transplantation as determined by the implanting center.
- Patient has adequate room in the chest as determined by 3-D imaging or other standard clinical assessments.
- Patient has read and understands the informed consent form (ICF) and has voluntarily provided informed consent.
Who cannot join
- Patient has contraindications to anticoagulation or antiplatelet therapies.
- Patient has coagulopathy defined by a platelet count < 50 k/µl.
- Patient has insufficient space in the chest to accommodate the BiVACOR pump.
- Patient has a body mass index (BMI) ≥ 35 kg/m2.
- Patient is highly pre-sensitized prior to pump implantation.
- Patient is unconscious and unresponsive.
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- Patient is on pre-implant extracorporeal membrane oxygenation (ECMO) for > 7 days.
- Patient is on pre-implant temporary MCSD for more than 21 days [e.g., Intra-aortic balloon pump (IABP), Impella, CentriMag, etc.] unless ambulatory and free from adverse effects associated with the MCSD.
- Patient is implanted with durable mechanical circulatory support (LVAD or RVAD).
- Patient experienced cerebrovascular accident (CVA) within three months of eligibility evaluation.
- Patient has severe end-organ dysfunction as evidenced by:
- Total bilirubin > 4.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy, and/or
- Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or renal replacement therapy dependence.
- Patient has severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen.
- Patient has primary pulmonary hypertension ≥ 8 Wood units.
- Patient has severe systemic light-chain amyloidosis.
- Patient has been diagnosed with severe cardiac cachexia or irreversible frailty.
- Patient has diabetes with advanced diabetic neuropathy with accompanying skin ulceration.
- Patient has a blood-borne infection within seven days of eligibility evaluation. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.
- Patient is pregnant or planning pregnancy.
- Patient has a co-morbidity or illness that would limit survival to less than two years.
- Patient has a current drug and/or alcohol addiction or known substance abuse.
- Patient has insufficient social support or a history of non-compliance with medical instructions as determined by the Investigator.
- Patient is participating in another clinical trial that may impact or confound the results of the BiVACOR TAH EFS.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Robert D. Dowling, MD, 513-585-4880, robert.dowling@thechristhospital.com
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Carmelo Milano, MD, 919-684-3243, carmelo.milano@duke.edu
- Recruiting
Texas Heart Institute / Baylor St. Luke's Medical Center
Houston, Texas, 77030
Joseph G. Rogers, MD, 731-790-9401, jrogers@texasheart.org
- Recruiting
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Francisco Arabia, MD, MBA, 602-377-9310, francisco.arabia@bannerhealth.com
About this 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 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.
- Conditions
- Heart Failure, Biventricular Failure
- Being tested
- BiVACOR TAH System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiVACOR TAH SystemDevice
The BiVACOR pump is an implantable rotary biventricular blood pump that uses magnetic levitation technology for increased durability to replace both ventricles of a failing heart. The device is intended to replace the diseased heart in patients suffering from heart failure to bridge the time to heart transplant.
| Study group | Role | What they receive |
|---|---|---|
| BiVACOR TAH | Experimental | 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. Receives: Device: BiVACOR TAH System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Endpoint
Survival on the original BiVACOR pump
Measured: 6 months or time of heart transplant (if prior to 6 months post pump implant)
Safety Endpoint
Evaluation of the safety of the BiVACOR TAH System using INTERMACS adverse event (AE) terms and definitions (INTERMACS Manual of Operations Version 5).
Measured: Through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start26 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BiVACOR Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174103
- Sponsor's protocol ID
- CP-0001
- Status last verified
- May 2026
- First submitted
- 8 Dec 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiVACOR® Total Artificial Heart Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06174103
- Acronym / sponsor ID
- CP-0001
- Conditions
- Heart Failure, Biventricular Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BiVACOR Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BiVACOR TAH | Experimental | Device: BiVACOR TAH SystemThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines or has univentricular heart failure in which LVAD support is not recommended. ISHLT Guidelines for Biventricular Support:
- Patient is categorized as INTERMACS Patient Profile Classification 2 or 3.
- Patient is classified as NYHA Class IV.
- Patient has a left ventricular ejection fraction (LVEF) ≤ 25%, with the exception of patients with restrictive or constrictive physiology.
- Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 L/min/m2 without inotropes if inotropes are contraindicated (e.g., restrictive or constrictive heart failure), and meets one of the following criteria:
Key exclusion criteria (24 listed)
- Patient has contraindications to anticoagulation or antiplatelet therapies.
- Patient has coagulopathy defined by a platelet count < 50 k/µl.
- Patient has insufficient space in the chest to accommodate the BiVACOR pump.
- Patient has a body mass index (BMI) ≥ 35 kg/m2.
- Patient is highly pre-sensitized prior to pump implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiVACOR TAH SystemThe BiVACOR pump is an implantable rotary biventricular blood pump that uses magnetic levitation technology for increased durability to replace both ventricles of a failing heart. The device is intended to replace the diseased heart in patients suffering from heart failure to bridge the time to heart transplant. | Device | BiVACOR TAH |
Primary outcome
Feasibility Endpoint
Time frame: 6 months or time of heart transplant (if prior to 6 months post pump implant)
Survival on the original BiVACOR pump
Safety Endpoint
Time frame: Through 6 months
Evaluation of the safety of the BiVACOR TAH System using INTERMACS adverse event (AE) terms and definitions (INTERMACS Manual of Operations Version 5).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiVACOR TAH System in people with Heart Failure and Biventricular Failure, run by BiVACOR Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Bartnikowski (657-540-9616, nicole.bartnikowski@bivacor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Endpoint (time frame: 6 months or time of heart transplant (if prior to 6 months post pump implant)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.