A Study of the CardiAQ-Edwards ™ Transcatheter Mitral Valve (TMV) System for patients requiring mitral valve replacement

The CardiAQ™ Transcatheter Mitral Valve System (TMVI) with the Transseptal Delivery Systems is intended to be used with patients suffering from moderate to severe mitral regurgitation (=3 +) requiring mitral valve replacement and whose native mitral annulus (major axis) dimension is appropriate for the available valve sizes and also been determined by a Cardiac Surgeon to be high risk or extreme risk for open heart surgery. The TMVI System is intended to offer permanent valve implantation using a catheter-based delivery system option for patients experiencing mitral valve regurgitation, and who are high risk or extreme risk for surgical treatment. The System is intended primarily for patients with secondary or functional mitral regurgitation, but could also be used to treat patients with primary or organic mitral regurgitation if their anatomy is suitable. The System is not intended for patients with a pre-existing (prosthetic) device in the mitral valve space. The intended users of the TMVI System are Interventional Cardiologists with structural heart disease experience, and Cardiac Surgeons with interventional skills. Investigators performing the implant procedure will receive device training via bench-top simulation and animal lab procedures prior to patient enrollment. Prior to device training, a presentation outlining each procedural step with an in-depth discussion on the unique aspects of the system and procedure will be conducted. The Investigator formal training will be performed by the Study Sponsor prior to patient enrollment at the study center. Echocardiographers/Radiologists/Cardiologists appointed by the Site Principal Investigator must undergo training prior to patient enrollment. This training includes a device description and discussion of the protocol. Following this training and before starting the study, at the discretion of the Echo Core Lab director, the appointed Echocardiographer may be requested to send to the Echo Core Lab at least one sample image examination for quality assessment. This sample has to be a generic exam, representative of the site’s standard quality, to be evaluated by the Echo Core Lab. This examination will allow for feedback and therefore corrections to acquisition techniques before the start of the study. The documentation for this training (participants, number of sessions, outcomes) will be held by the Investigator in the Site Study Binder and by the Sponsor. Training will be documented on a training record provided by the Study Sponsor, which the trainee must sign and date. The training of study support staff must be completed and documented according to the specific study tasks delegated to them by the Investigator. The System is intended for use in a catheterization lab, surgical suite, or hybrid suite. The procedure will be performed at hospital facility that has a post-cardiac intensive care unit . The Transseptal Delivery System is used to obtain transseptal access for delivery, positioning, and deployment of the valve TMV. It consists of the main delivery unit with a 107 cm working length, a 33 Fr OD ePTFE capsule for housing and securing the TMV and a 24 Fr integrated introducer sheath to maintain hemostasis at the femoral incision throughout the procedure. The access site is either a percutaneous insertion or a surgical cut down at either the left or right femoral or iliac vein to gain access to the right atrium. A transseptal puncture is made between the right and left atria and a 0.035 inch guidewire is used to gain access to the left ventricle via the left atrium. The atrial septum is dilated using an off the shelf balloon catheter. A second balloon is inflated and tracked between the LVOT and the left atrium to confirm the wire path is free from mitral chordal entanglement. The delivery system is inserted through the femoral vein over the guidewire. With the distal tip of the delivery system in the left atrium, the delivery system capsule is flexed into location through rotation of the flex wheel. Once in position, the retraction wheel is rotated to begin the TMV deployment process. Once the left ventricular anchors are fully expanded and the native mitral leaflets are captured, the TMV is released from the delivery system. The tapered tip is pulled back through the TMV. The delivery system is unflexed and retracted to free the attachment mechanisms from the TMV. Once free of the TMV, the attachment mechanisms are re-sheathed and the delivery system is pulled proximally in order to be removed from the body. The Bioprosthesis operates similarly to a healthy native mitral valve and prevents backflow from the left ventricle into the left atrium during systole. It is designed to conform to the natural shape of the annulus in three dimensions to ensure that the systolic load during closing is distributed evenly. The Bioprosthesis anchoring system extends between the chordae tendinae of the subvalvular apparatus to engage and capture the free-edge of the native mitral leaflets (anterior and posterior). This helps to dissipate the systolic load, minimize paravalvular leak, and reduce the risk of left ventricular outflow tract obstruction or systolic anterior leaflet motion. The TMVI system is intended to offer permanent valve replacement for all participants.