NCT06174103
BiVACOR® Total Artificial Heart Early Feasibility Study
Recruiting · Not Applicable · BiVACOR Inc. · registry updated 2026-09-28
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
Exclusion
- 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.