BiVACOR® Total Artificial Heart Early Feasibility Study

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06174103
Study type	Interventional
Source	BiVACOR Inc.
Contact	Angela Parsons
Phone	562-732-4272
Email	angela.parsons@bivacor.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2024
Completion date	December 2026

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