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
Study of OPTIMIZER System in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF)
Sponsor: Impulse Dynamics, Inc
Enrolling: Male and Female Patients
Study Length: 2 Years
IRB Number: AAAT9371
U.S. Govt. ID: NCT05855135
Contact: Raghd Ahmed: / ria2120@cumc.columbia.edu
Additional Study Information: You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy called the OPTIMIZER System. The OPTIMIZER INTEGRA CCM-D System, also known as a Cardiac Contractility Modulation Defibrillator, is an investigational device system that combines CCM therapy and ICD therapy into one device. Investigational means that the study device is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA). If you choose to be part of this research, you will be asked to provide blood and will undergo procedures that might be different from a regular medical examination. This study will involve reviewing your medical history, physical assessment, review medication, imaging, blood draw (a small needle used to draw blood), 6-minute walk test and ECG (electrocardiogram- can detect heart beats that are too fast or too slow). You will also be asked to complete a few questionnaires regarding your health status. Your participation is expected to last up to 2 years.
Investigator
Hirad Yarmohammadi, MD, MPH
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with Heart Failure with Reduced Ejection Fraction (HFrEF)? Yes No
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For more information, please contact:
Raghd Ahmed
ria2120@cumc.columbia.edu