Edwards Lifesciences

This study is testing a new device called the Edwards EVOQUE eos mitral valve replacement system. It is designed for people with a leaky mitral valve who are at high risk for open-heart surgery. The goal is to see if the device is safe and works well. About 123 participants will …

This study tests a new balloon-expandable heart valve (SAPIEN X4) in 1,234 people with severe aortic stenosis, a condition where the heart's main valve narrows. The goal is to see if the valve is safe and works well. Participants receive the valve through a tube in their leg, avo…

This study tests a device called the Edwards Cardioband FIT, designed to repair the tricuspid valve in people with moderate or worse leakage. About 75 participants who still have symptoms despite medication will receive the device. The goal is to see if the procedure is safe and …

This study tests a new device called the Edwards EVOQUE system to replace the tricuspid valve in people whose valve leaks severely. The goal is to see if the device can safely reduce the leak and improve symptoms like shortness of breath and fatigue. About 864 adults with severe …

This study tracks how well a new heart valve system works in 150 people born with heart defects that cause a leaky pulmonary valve. The valve is placed using a thin tube through a blood vessel, avoiding open-heart surgery. Researchers are checking if the valve is placed correctly…

This study tests a new device combination (Alterra Prestent and SAPIEN 3 valve) to repair a leaky pulmonary heart valve in people born with heart defects. About 86 participants with moderate or severe leakage will get the device through a tube in a blood vessel, avoiding open-hea…

This study is testing a new heart valve (SAPIEN 3) for people born with heart defects that cause their pulmonary valve to leak or become blocked. About 150 participants will receive the valve through a tube in a blood vessel, avoiding open-heart surgery. The goal is to see if the…

This study tests a new way to replace a failing mitral heart valve without open-heart surgery. It involves 53 people whose surgically implanted mitral valve is no longer working well. Doctors use a catheter to place a new valve (SAPIEN 3) inside the old one. The main goal is to s…

This study is testing a new device that creates a small opening inside the heart to lower pressure and ease symptoms in people with heart failure. About 71 participants who have severe symptoms despite standard medications will receive the implant. The goal is to see if the devic…

This study tests a device called the Edwards APTURE Transcatheter Shunt System in 100 people with heart failure. The device is placed in the heart to help reduce pressure and improve symptoms like shortness of breath. Half of the participants get the real device, and the other ha…

This study tests a new device called PASCAL against an existing device, MitraClip, for repairing leaky mitral valves in the heart. About 1,200 people with mitral regurgitation who are too high-risk for open-heart surgery took part. The goal is to see if PASCAL is as safe and effe…

This study tests a new device called EVOQUE to replace the tricuspid valve in people with a leaky heart valve that causes symptoms despite medication. About 228 participants will get the device to see if it safely reduces the leak and improves their condition. The goal is to cont…

This study follows 255 Chinese patients who received the INSPIRIS RESILIA aortic valve to replace a faulty heart valve. Researchers track safety issues like valve-related death, valve damage, bleeding, and stroke over several years. The goal is to see how well the valve works in …

This study follows about 500 people who need a new mitral valve to see how well the MITRIS RESILIA valve works in everyday use. Researchers will check safety, how the valve performs, and patient recovery over time. The goal is to gather real-world data to help doctors and patient…

This study looks at how well the SAPIEN 3 Ultra heart valve works in 200 people with severe, symptomatic aortic stenosis who are at intermediate or higher risk for open-heart surgery. Researchers are checking if the valve works as intended and tracking safety issues like stroke, …

This study tests a new, less invasive heart valve (SAPIEN 3) for people with severe aortic stenosis who are at low risk for standard surgery. About 1,000 participants will be randomly assigned to get the new valve or traditional open-heart surgery. The goal is to see if the new v…

This study tests a new heart valve device (CENTERA THV) in 101 people with severe aortic stenosis who are at intermediate risk for surgery. The valve is placed without open-heart surgery. The main goal is to see if it is safe and works well. This is not a cure, but aims to contro…

This study tests a small device called the APTURE shunt, which is placed in the heart to help reduce fluid buildup and ease symptoms of heart failure. About 45 people with moderate to severe heart failure and reduced pumping function will take part. The main goal is to see if the…

This study looks at people who already have an INSPIRIS RESILIA aortic heart valve that is not working well and need a new valve placed inside it. The goal is to track safety issues like death, stroke, or bleeding, and measure how well the new valve expands. About 50 participants…