Clinical Trials

Are you 65 years old or older, and do you have severe primary mitral regurgitation? This condition — also called degenerative mitral regurgitation — happens when there is a problem with the mitral valve itself or its supporting tissue, leading to a leaky valve. This study is comparing the safety and effectiveness of two different ways of repairing the mitral valve: transcatheter edge-to-edge repair and surgical repair. To participate in this study, your healthcare provider must determine that you are a candidate for both mitral valve transcatheter edge-to-edge repair and surgical repair. This study takes place in multiple locations across the United States and Canada.

The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.