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Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06174103). This is a study registration, not published results. Lead sponsor: BiVACOR Inc.. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Heart Failure, Biventricular Failure. Interventions: DEVICE: BiVACOR TAH System. Primary outcome measures: Feasibility Endpoint , 6 months or time of heart transplant (if prior to 6 months post pump implant); Safety Endpoint , Through 6 months. Brief 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.