Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects with Heart Failure and Reduced Ejection Fraction (INTEGRA-D)
The investigational device is called the OPTIMIZER INTEGRA CCM D System (hereinafter referred to as the CCM-D System It is an implantable cardiac device system that combines cardiac contractility modulation, also known as CCM ™ and implantable cardioverter defibrillator ( modules into one device. CCM D is also known as a “Cardiac Contractility Modulation Defibrillator”. The Optimizer® Smart System which deliver s CCM therapy alone, is indicated in the US to improve the 6 minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy ( are not indicated for cardiac resynchronization therapy (CRT) and have an LVEF ranging from 25% to 45%. Studies have demonstrated the benefits of CCM therapy in the moderate to severe heart failure patient population. These studies consistently show an improvement in exercise tolerance and quality of life after 6 months of CCM therapy. The addition of the ICD module to the CCM device does not alter the effectiveness of CCM therapy in any way.The benefits of ICDs on prevention of SCD and decreased mortality are well known.
Principal Investigator: Dr. Nikhil Panda
Study Coordinator: Marie White
This study is actively enrolling patients. To learn more about INTEGRA-D and how you can join contact our research office at (314) 289-7690
This study is funded by the Foundation through Impulse Dynamics (USA), Inc.
Study Coordinator: Marie White
This study is actively enrolling patients. To learn more about INTEGRA-D and how you can join contact our research office at (314) 289-7690
This study is funded by the Foundation through Impulse Dynamics (USA), Inc.