Edwards Lifesciences

This study is testing a new heart valve (SAPIEN 3) in 108 people who have a dysfunctional right ventricle outflow tract (RVOT) due to a congenital heart defect or a previous valve replacement. The goal is to see if the valve is safe and effective at improving blood flow and reduc…

This study will follow up to 250 adults who receive the KONECT RESILIA device, which replaces both the aortic valve and the ascending aorta in one surgery. The goal is to see how safe and effective the device is in real-world use. Participants must have a diseased aortic valve an…

This trial is testing a new heart valve called SAPIEN X4/X4S in over 1,200 people with severe aortic stenosis, a condition where the heart's aortic valve narrows. The valve is inserted through a catheter, avoiding open-heart surgery. Researchers are measuring how many patients di…

This study tests a device called the Edwards PASCAL System, which is threaded through a blood vessel to repair a leaky tricuspid valve in the heart. It is for people with severe symptoms who are not good candidates for open-heart surgery. About 1,270 participants will be randomly…

This early study tests a new device called the INNOVALVE system for people with a leaky mitral valve who are too high-risk for open-heart surgery. The device is delivered through a catheter to repair the valve. Researchers will check if it is safe and works well in 65 participant…

This study tests a new device called SAPIEN M3 that can replace a leaky mitral heart valve using a thin tube inserted through a vein in the leg. It is for people with severe symptoms who cannot have standard surgery or other less invasive treatments. The goal is to see if the dev…

This study is testing a new artificial heart valve (MITRIS RESILIA) in 250 Chinese patients who need their mitral valve replaced. The goal is to see how safe and well the valve works over time by measuring blood flow and leaks. Participants must be 18 or older and willing to foll…

This study is testing a new heart valve called the SAPIEN X4 in 200 people whose existing artificial aortic valve is failing. The valve is placed using a thin tube through an artery, avoiding open-heart surgery. The goal is to see if it is safe and effective at improving survival…

This study compares two approaches for people aged 65+ with moderate aortic stenosis (a narrowed heart valve): either getting a new valve placed through a thin tube (TAVR) or just having regular check-ups. The goal is to see if early treatment prevents death or heart failure bett…

This study is tracking 500 people who receive the INSPIRIS RESILIA aortic valve during surgery. Researchers will measure how well the valve works by checking blood flow and leakage over time. The goal is to see how the valve performs in everyday medical practice.