The purpose of this trial is to demonstrate 30-day safety and effectiveness outcomes of the KARDION CORY P4 System (study device) in subjects who require hemodynamic support during PCI procedure.

The CORCINCH-HF Study is designed to evaluate the safety and efficacy of the AccuCinch^® Ventricular Restoration System, a minimally invasive, transcatheter approach to treat the enlarged left ventricle. The AccuCinch System is designed to improve the structure and function of the heart and help bring relief to HF patients who remain symptomatic despite current guideline-directed medical care, including cardiac resynchronization therapy. These patients often have few options, such as implantation of a left ventricular assist device (LVAD), heart transplant, or palliative care.

Patients with heart failure often develop enlargement of their heart. This can cause the mitral valve to malfunction. When the enlargement of the heart causes the mitral valve to malfunction, this is called functional mitral regurgitation. The CARILLON Mitral Contour System is an investigational permanent implant developed for the treatment of functional mitral regurgitation (FMR). The implant is placed using a non-surgical (catheter-based) technique in the Coronary Sinus (CS), a vein on the outside of the heart which is adjacent to the mitral valve. This simple procedure is designed to reshape the mitral valve, reduce valve leakage and thus reduce FMR.

Patients with severe, symptomatic AS often receive a minimally invasive procedure known as transcatheter aortic valve replacement (TAVR) to replace their aortic valve. But for the more than two million people in the U.S. living with moderate, symptomatic AS, TAVR is not included in current treatment guidelines. The Medtronic-sponsored EXPAND II Pivotal Trial will, for the first time, evaluate the safety and effectiveness of the company’s Evolut™ PRO+ and Evolut™ FX TAVR prosthetic valves in patients with moderate, symptomatic AS.