RecruitingNot ApplicableNCT06174103

BiVACOR® Total Artificial Heart Early Feasibility Study


Sponsor

BiVACOR Inc.

Enrollment

5 participants

Start Date

Jun 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This early feasibility study is testing the BiVACOR total artificial heart — a mechanical device that completely replaces a failing heart — in patients whose hearts are so damaged that both sides (left and right ventricles) are failing and who need a bridge to transplant or permanent support. **You may be eligible if...** - You have severe, irreversible failure of both sides of your heart that cannot be managed with medicines - You are on a heart transplant waiting list or are being considered for one - Your heart failure meets specific measurements showing both right and left sides are critically weak - Standard single-ventricle assist devices are not appropriate for your situation **You may NOT be eligible if...** - You have had a recent major stroke or significant blood clotting disorder - You have active, uncontrolled infection or sepsis - You have severe organ failure (kidneys, liver, lungs) that makes surgery too risky - You have a condition that makes you ineligible for heart transplant in the long term Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBiVACOR 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.


Locations(4)

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

Duke University Hospital

Durham, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Texas Heart Institute / Baylor St. Luke's Medical Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06174103


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