AIM HIGHer Clinical Trial for Heart Failure with Higher Ejection Fraction
This study is testing a treatment called Cardiac Contractility Modulation (CCM) therapy using the OPTIMIZER™ Smart Mini System for people with heart failure. Specifically, it's for those whose heart pumps blood with a higher-than-normal force (ejection fraction between 40% and 70%). The study aims to see if CCM therapy can improve how far you can walk in 6 minutes and your overall health as measured by a heart failure questionnaire. You could join if you are 18 or older, have symptomatic heart failure, and have been hospitalized for heart failure or had an urgent heart failure visit recently. The study plans to enroll 1500 participants, but its current status is unclear.
- Study design
- This is an interventional study where participants will be randomly assigned to receive CCM therapy turned ON or OFF for the first 18 months. The study is blinded, meaning neither you nor your doctors will know which group you are in during this time.
- What's involved
- All eligible participants will have the OPTIMIZER™ Smart Mini System implanted. Your health will be assessed at 6 months and device-related complications will be monitored for 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Part I of the trial will continue to be followed through the end of Part II, which could be for an additional 1050 participants beyond the initial 450.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Assessment of CCM in HF With Higher Ejection Fraction
At a glance
Conditions
NCT05064709
Where you'd take part
This study runs at 105 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
AdventHealth Orlando
Orlando, Floridastudy coordinator listed
Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Arizona Heart Rhythm
Phoenix, Arizonastudy coordinator listed
Recruiting
Ascension Medical Group St. Vincent
Indianapolis, Indianastudy coordinator listed
Recruiting
Ascension Providence Hospital
Southfield, Michiganstudy coordinator listed
Recruiting
Ascension Seton
Austin, Texasstudy coordinator listed
Recruiting
Atlantic Health System- Morristown Medical Center
Morristown, New Jerseystudy coordinator listed
Recruiting
AtlantiCare Regional Medical Center
Pomona, New Jerseystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Javed Butler, MD, MPH, MBA · PRINCIPAL_INVESTIGATOR · Baylor Scott and White Research Institute, Dallas, Texas
- Oussama Wazni, MD, MBA · PRINCIPAL_INVESTIGATOR · Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
Who to contact
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Inclusion
What this trial measures
- Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months.6 months
Demonstrate that CCM therapy improves functional capacity in subjects with symptomatic heart failure with LVEF ≥40% and ≤70%. Compare the changes in functional capacity, as measured by the 6-minute walk distance (6MWD), from baseline to 6-months following the randomization date between the two study groups.
- Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS).6 months
Demonstrate that CCM therapy improves health status in subjects with symptomatic heart failure with LVEF ≥40% and ≤60%. Compare the changes in health status, as measured by the KCCQ CSS, from baseline to 6-months following the randomization date between the two study groups.
- Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant12 months
Compare the composite incidence of Optimizer device-related and procedure-related SAEs (complications) for available data collected from implant to 12 months after the Optimizer implantation procedure to a performance goal of 75% free of complications.
- Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS).18 months
Demonstrate that CCM therapy improves a composite endpoint of cardiovascular mortality at 18-months, heart failure hospitalizations at 18-months, urgent heart failure visits requiring IV diuretics at 18-months and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) at 12-months. Comparison of a hierarchical composite endpoint between the two study groups will be based on the Finkelstein-Schoenfeld global rank method.