This study focuses on individuals who have tricuspid regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly, causing the blood to leak backwards. The study will evaluate the use of an investigational experimental device called the Medtronic Intrepid TTVR System. The TTVR implant is made of a bioprosthetic valve set inside a flexible metal structure that is placed within the patient’s own tricuspid valve. The purpose of the TTVR bioprosthetic valve device is to reduce or normalize the leak of the native diseased valve; it allows blood to flow only in the forward direction, relieving tricuspid regurgitation. The device is intended to be placed through a less invasive procedure (through the groin) and without requiring heart-lung bypass support or stopping the heart.
What is the full name of this clinical trial?
Evaluation of the Safety and Performance of The Medtronic Intrepid Transcatheter Tricuspid Valve Replacement System with Transfemoral access in Patients with symptomatic severe tricuspid regurgitation The Early Feasibility Study of the TTVR Transfemoral System