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BiVACOR® Total Artificial Heart Early Feasibility Study

NCT06174103 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-07-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • BiVACOR Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2025-08-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174103 on ClinicalTrials.gov