The AIM HIGHer Clinical Trial is studying a new way to help people with heart failure (when the heart can't pump blood well) using a treatment called Cardiac Contractility Modulation (CCM). This study is for adults with heart failure and a Left Ventricular Ejection Fraction (LVEF) between 40% and 70%. LVEF measures how well the heart pumps blood. Participants will get a device called the OPTIMIZER Smart Mini System implanted to see if it helps their heart work better. Some people will have the device turned on (CCM ON) while others will not (CCM OFF) for the first 18 months. After that, everyone will have the device turned on. The trial is happening at 150 sites in the US and 75 sites outside the US.
- Length: The study lasts 18 months, with follow-up visits.
- Participation: Subjects must be at least 18 years old with specific heart conditions.
- Risks: Participants should not have severe heart issues or other medical conditions that could affect the study.
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