BiVACOR (NCT06174103)

BiVACOR® Total Artificial Heart Early Feasibility Study

PI: Joseph G. Rogers, MD

Sponsor: BiVACOR, Inc.

ACTIVE ENROLLING

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. Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects.

Eligibility Requirements

1. Patient is 18 to 70 years of age.

2. 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.

3. Patient is categorized as INTERMACS Patient Profile Classification 2 or 3.

4. Patient is classified as NYHA Class IV.

5. Patient has a left ventricular ejection fraction (LVEF) ≤ 25%, with the exception of patients with restrictive or constrictive physiology.

6. Patient is eligible for cardiac transplantation as determined by the implanting center.