REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Brief description of study

The purpose of this study is to evaluate the safety and effectiveness (or how well the device works) of the LOTUS EdgeTM Valve System used with either LotusTM or iSleeveTM Introducer Sets for transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis (narrowing) who are considered at intermediate risk for surgical valve replacement. Severe aortic valve stenosis is the narrowing of the heart’s major valve (through which your heart pumps blood to the rest of your body). This narrowing reduces the amount of blood that can get to the body. Severe aortic valve stenosis is caused by stiffening and hardening of the heart valve leaflets (tissue that opens and closes in the heart valve) so that the valve cannot work properly. If left untreated, excessive strain put on the heart muscle will eventually cause it to fail or lead to other serious complications. Many patients with severe aortic valve stenosis are successfully treated with open-heart surgery to replace the valve. This procedure has significant risks for patients who are older, have other heart disease, or have general health problems. Because of your condition, your physician feels that you are at intermediate risk of experiencing serious complications such as stroke or death during open-heart surgery. Therefore a less invasive procedure known as a transcatheter aortic valve replacement (TAVR) may be more appropriate for you.

Clinical Study Identifier: s18-02050 Identifier: NCT03618095

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