BiVACOR® Total Artificial Heart Early Feasibility Study
BiVACOR Inc.
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 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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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: 1. Biventricular failure with at least two of the following hemodynamic and/or echocardiographic measurements. 1. Right ventricular ejection fraction (RVEF) ≤ 30% 2. Right ventricular stroke work index (RVSWI) ≤ 0.25 g/m/beat/m…
Interventions
- DeviceBiVACOR TAH System
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.
Locations (4)
- Banner - University Medical Center PhoenixPhoenix, Arizona
- Duke University HospitalDurham, North Carolina
- The Christ HospitalCincinnati, Ohio
- Texas Heart Institute / Baylor St. Luke's Medical CenterHouston, Texas