BiVACOR® Total Artificial Heart Early Feasibility Study
NCT06174103
This study is recruiting at 4 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Heart Failure
- Biventricular Failure
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- BiVACOR Inc.
- Last updated on ClinicalTrials.gov
- September 28, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Banner - University Medical Center Phoenix · Phoenix, AZ
North Carolina · 1
- Duke University Hospital · Durham, NC
Ohio · 1
- The Christ Hospital · Cincinnati, OH
Texas · 1
- Texas Heart Institute / Baylor St. Luke's Medical Center · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.