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.
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Dr. Nikhil Panda, MD, Clinical Cardiac Electrophysiologist at the VA St Louis Health Care System (STLVAHCS), has been selected as the Principal Investigator for a new clinical device trial INTEGRA-D, sponsored by Impulse Dynamics.
VA St. Louis Health Care System has distinguished itself as the first Veterans Affairs facility in the nation, as well as the first hospital in Missouri, to begin recruitment for this clinical trial. This trial will be conducted at the St. Louis VA Health Care System under the supervision of Dr. Panda and his cardiac electrophysiology research team. The STLVAHCS is already providing CCM devices to Veterans and was one of the first VA facilities in the nation to offer this FDA-approved technology. The device utilized in this trial is unique in its capabilities. Dr. Panda notes the potential benefits for all Veterans, stating, "Previously, patients required two separate devices placed in their left and right chest through two different procedures. They can now receive both technologies in a single device during one procedure”. |
The main inclusion/exclusion criteria for this study are:
-Primary or secondary indication for an ICD
-Class C or D heart failure. Note: these are AND/OR criteria (symptoms, cardiac chamber enlargement, E/E’ of >15, mod severe ventricular hypertrophy, mod severe valvular regurgitation or obstruction lesion
-Elevated BNP level
-Not eligible for CRT and no indication for brady pacing.
Dr. Panda and his team invite all VA Providers to reach out for consultation if you believe you have a patient that aligns with these basic criteria.
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.
-Primary or secondary indication for an ICD
-Class C or D heart failure. Note: these are AND/OR criteria (symptoms, cardiac chamber enlargement, E/E’ of >15, mod severe ventricular hypertrophy, mod severe valvular regurgitation or obstruction lesion
-Elevated BNP level
-Not eligible for CRT and no indication for brady pacing.
Dr. Panda and his team invite all VA Providers to reach out for consultation if you believe you have a patient that aligns with these basic criteria.
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.