The study focuses on patients with severe symptomatic mitral regurgitation, which is when the heart's mitral valve doesn't close tightly, causing blood to flow backward into the heart. The trial tests the Medtronic Intrepid™ TMVR System, a device placed inside the heart without traditional surgery, using a tube called a catheter. This is a global study conducted at multiple centers, where every participant will receive the study device.
Eligibility: Patients must have serious symptoms and cannot be treated with approved repair methods. They should not have any implanted mitral valve devices, certain heart conditions, or require emergency surgery.
- Participants will receive the device in a non-randomized way, meaning everyone gets the same treatment.
- Participants need to be evaluated by a special heart team to confirm eligibility.
- The study is interventional, meaning it involves active treatment with the study device.
Consider joining if you have severe mitral regurgitation and are unable to undergo other valve treatments. Discuss potential benefits and risks, such as the newness of the device and possible complications, with your doctor.