The Realism study is a prospective, multi-center, continued access registry of the Everest II study. The Realism study consists of two arms: a high risk arm and a non-high risk arm. Up to 300 patients will be enrolled in the study at clinical sites in the US. Patients will undergo 30-day, six-month and 12-month clinical follow-up. Realism will collect new information regarding functional capacity following treatment with the MitraClip device.
The MitraClip system is currently being evaluated in the US as a non-surgical treatment option for patients suffering from the effects of mitral regurgitation (MR). Everest II, the only randomized trial comparing a percutaneous mitral repair device to mitral valve surgery, successfully completed enrollment in 2008.
According to the company, the MitraClip system is the only commercially available treatment option for non-surgical mitral valve repair in Europe.
Ferolyn Powell, president and CEO of Evalve, said: Initiating enrollment in Realism is an important milestone for Evalve. Realism allows participating Everest investigators continued access to the MitraClip therapy for patients suffering from MR.
As we make progress toward filing the MitraClip system premarket approval application with the FDA, this study also allows physicians to gain additional experience with the system and enables patients to potentially benefit from a less invasive treatment option.