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

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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

Brief description of study

The purpose of this study is to determine if the combination of Cardiac Contractility Modulation (CCM®) and implantable cardioverter-defibrillator (ICD), as an investigational device (OPTIMIZER INTEGRA CCM-D System) can effectively defibrillate and treat episodes of ventricular tachycardia and/or ventricular fibrillation (VT/VT) should any occur.

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).

Clinical Study Identifier: s23-00164

ClinicalTrials.gov Identifier: NCT05855135

Principal Investigator: Chirag R. Barbhaiya.

Other Investigators: Tajinderpal Saraon, Larry A Chinitz, Randal Ian Goldberg.

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