Plain-English translation of NCT05064709 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Heart Failure research guide →This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
The AIM HIGHer trial is testing a treatment called Cardiac Contractility Modulation (CCM), delivered through an implanted device called the Optimizer Smart Mini System, to see if it can help people with heart failure who still have reasonable heart pumping strength. About 1,500 people will receive the device, and researchers will compare outcomes between those who use the device right away and those who wait 18 months to turn it on.
Most heart failure treatments focus on people whose hearts are severely weak, but many people have heart failure with preserved or moderately reduced pumping strength and still struggle with symptoms. This trial is testing whether this treatment can help this overlooked group of patients.
You likely qualify if…
You likely don't qualify if…
All participants will receive the Optimizer device implanted through a minor surgical procedure. You will then be randomly assigned to either have the device turned on immediately or turned off for the first 18 months (the sham group). Throughout the study, you'll attend regular clinic visits for check-ups, heart function tests, and questionnaires about your symptoms and quality of life. The trial lasts 18 months in the initial phase, with an option to continue longer, and those in the sham group will have their device activated after 18 months.
AI-generated summary from trial data · Jul 1, 2026 · Not medical advice
United States