BiVACOR® Total Artificial Heart Early Feasibility Study

Inclusion Criteria:

• Patient has severe, irreversible biventricular heart failure and is eligible forbiventricular mechanical circulatory support based on the International Society ofHeart and Lung Transplantation (ISHLT) guidelines or has univentricular heartfailure in which LVAD support is not recommended. ISHLT Guidelines for BiventricularSupport:

1. Biventricular failure with at least two of the following hemodynamic and/orechocardiographic measurements.

2. Right ventricular ejection fraction (RVEF) ≤ 30%

3. Right ventricular stroke work index (RVSWI) ≤ 0.25 g/m/beat/m2

4. Tricuspid annular plane systolic excursion (TAPSE) ≤ 14 mm

5. Right ventricular (RV) to left ventricular (LV) end-diastolic diameterratio > 0.72

6. Central venous pressure (CVP) > 15mmHg

7. CVP to pulmonary capillary wedge pressure (PCWP) ratio > 0.63

8. Tricuspid insufficiency grade 4

9. Pulmonary artery pressure index (PAPi) < 2

10. Treatment-refractory recurrent and sustained ventricular tachycardia orventricular fibrillation in the presence of untreatable arrhythmogenicpathologic substrate.

11. Heart failure due to restrictive or constrictive physiology (e.g., hypertrophiccardiomyopathy, cardiac amyloidosis/senile or other infiltrative heartdisease).

• 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 ofpatients with restrictive or constrictive physiology.

• Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 L/min/m2 withoutinotropes if inotropes are contraindicated (e.g., restrictive or constrictive heartfailure), and meets one of the following criteria:

1. Is on optimal medical management (OMM), based on current heart failure practiceguidelines for at least 45 out of the last 60 days and is failing to respond oris not able to tolerate OMM; or

2. Has advanced heart failure for at least 14 days and is dependent on anintra-aortic balloon pump (IABP) or similar temporary mechanical circulatorysupport device (MCSD) for at least seven days.

• Patient is eligible for cardiac transplantation as determined by the implantingcenter.

• Patient has adequate room in the chest as determined by 3-D imaging or otherstandard clinical assessments.

• Patient has read and understands the informed consent form (ICF) and has voluntarilyprovided informed consent.

Exclusion Criteria:

• 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-aorticballoon pump (IABP), Impella, CentriMag, etc.] unless ambulatory and free fromadverse effects associated with the MCSD.

• Patient is implanted with durable mechanical circulatory support (LVAD or RVAD).

• Patient experienced cerebrovascular accident (CVA) within three months ofeligibility evaluation.

• Patient has severe end-organ dysfunction as evidenced by:

1. Total bilirubin > 4.0 mg/dL or cirrhosis confirmed by imaging or positivebiopsy, and/or

2. Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or renal replacementtherapy dependence.

• Patient has severe chronic obstructive pulmonary disease (COPD) or restrictive lungdisease 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 skinulceration.

• Patient has a blood-borne infection within seven days of eligibility evaluation.Positive blood cultures reflective of contaminants (e.g., Staphylococcusepidermidis) 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 twoyears.

• 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 medicalinstructions as determined by the Investigator.

• Patient is participating in another clinical trial that may impact or confound theresults of the BiVACOR TAH EFS.