A study to evaluate the safety and effectiveness of the Navigate Cardiac Structures, Incorporated (NCSI) replacement heart valve and delivery system in high risk cardiac surgical patients with regurgitant (leaky) tricuspid valves.

Abstract

While traditional surgical procedures for heart valve replacement generally require a large incision in the middle of the chest and use of a heart-lung machine, the GATE tricuspid valve is delivered through a comparatively small incision in the chest or neck in a beating heart. This approach can be referred to as being “minimally invasive.” The procedure includes use of a catheter delivery system, through which the replacement valve is delivered to the heart.

By replacing the diseased native valve, the purpose of the study is to demonstrate that the GATE system provides a safe and effective means of restoring valve function and improving quality of life for patients at high risk for traditional cardiac surgery.

The study hypothesizes that replacing the diseased tricuspid valve in a minimally invasive manner will restore valve function, minimize regurgitation (leaking) and lead to improved quality of life.