EVEREST II Clinical Trial – Continued Access Registry
The purpose of this study is to continue evaluation and monitoring of the safety and effectiveness of an investigational device that repairs the mitral valve. The device is called the MitraClip System. Evalve, Inc., of Menlo Park, Calif., is the company that makes this device, which consists of a delivery catheter (tube) and an implantable clip (called the MitraClip device). The delivery catheter guides the MitraClip device into place so that it can be attached to the leaflets of your mitral valve. Once the MitraClip device is in place on your mitral valve, the delivery catheter is removed. The MitraClip device has not been approved by the U.S. Food and Drug Administration for use except in research studies such as this one.
You may be eligible to participate in this study if you:
- Are over the age of 18
- Are not be enrolled in other clinical trials involving investigational drugs or devices
- Do not have any bleeding disorders
- Have had no prior mitral valve surgery or any currently implanted mechanical prosthetic mitral valve
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.