NCT06174103

BiVACOR® Total Artificial Heart Early Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: BiVACOR Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Biventricular Failure

Interventions

Type	Name	Description
DEVICE	BiVACOR 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.

Timeline

• Start date: 2024-06-26
• Primary completion: 2025-08-01
• Completion: 2026-12-01
• First posted: 2023-12-18
• Last updated: 2024-07-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study