What is the Purpose of this Study?
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.
Eligibility
- * Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
- * Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- * Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
- * New York Heart Association (NYHA) Function Class II or greater
Where can I participate?
Beverly
More about this Clinical Trial
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