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New treatment option for Heart Failure
Official title BiVACOR® Total Artificial Heart Early Feasibility Study
ClinicalTrials.gov ID: NCT06174103
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the...
- 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
You likely can't join if
- 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.
See the full eligibility criteria
Who can 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...
- 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
- 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.
What rules you out
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Durham, North Carolina, United States; Cincinnati, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.