Assessment of CCM in HF With Higher Ejection Fraction
Condition(s) studied
Investigational drug(s) / intervention(s)
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System: The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.
OPTIMIZER™ Smart Mini System: The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.
Study summary
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
Eligibility
Primary outcome measure(s)
- 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 implant — 12 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.
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| Grandview Medical Group Research, LLC | Birmingham | Alabama | Recruiting |
| CardioVascular Associates of Mesa | Mesa | Arizona | Recruiting |
| Southwest Cardiovascular Associates | Mesa | Arizona | Recruiting |
| HonorHealth | Scottsdale | Arizona | Recruiting |
| Pima Heart and Vascular | Tuscon | Arizona | Recruiting |
| University of California San Diego | La Jolla | California | Recruiting |
| USC Keck School of Medicine | Los Angeles | California | Recruiting |
| Cedars Sinai Medical Center | Los Angeles | California | Recruiting |
| Valley Clinical Trials- Northridge | Northridge | California | Recruiting |
| Sequoia Hospital | Redwood City | California | Recruiting |
| Nuvance Health - Danbury Hospital | Danbury | Connecticut | Recruiting |
| Hartford Healthcare | Hartford | Connecticut | Recruiting |
| Nouvelle Clinical Research LLC | Cutler Bay | Florida | Recruiting |
| Baptist Health South Florida | Miami | Florida | Recruiting |
| AdventHealth Orlando | Orlando | Florida | Recruiting |
| Clinical One Research | Orlando | Florida | Recruiting |
| Cleveland Clinic Foundation - Florida Weston Hospital | Weston | Florida | Recruiting |
| Northeast Georgia Health System | Gainesville | Georgia | Recruiting |
| Ascension Medical Group St. Vincent | Indianapolis | Indiana | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| MercyOne Iowa Heart | West Des Moines | Iowa | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| Baptist Health Lexington | Lexington | Kentucky | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Henry Ford St. John Hospital | Detroit | Michigan | Recruiting |
| Ascension Providence Hospital | Southfield | Michigan | Recruiting |
| Trinity health- Michigan Heart | Ypsilanti | Michigan | Recruiting |
| Minneapolis Heart Institute at Abbott Northwestern Hospital | Minneapolis | Minnesota | Recruiting |
| St. Lukes Hospital Kansas City (Mid America Heart Institute) | Kansas City | Missouri | Recruiting |
| Bryan Heart | Lincoln | Nebraska | Recruiting |
| Catholic Medical Center | Manchester | New Hampshire | Withdrawn |
| Our Lady of Lourdes | Camden | New Jersey | Recruiting |
| Cooper Hospital- Cardiovascular Associates of Delaware Valley | Haddon Heights | New Jersey | Recruiting |
| Atlantic Health System- Morristown Medical Center | Morristown | New Jersey | Recruiting |
| Rutgers New Jersey Medical School | Piscataway | New Jersey | Withdrawn |
| AtlantiCare Regional Medical Center | Pomona | New Jersey | Recruiting |
| Buffalo General | Buffalo | New York | Recruiting |
| Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC | Poughkeepsie | New York | Recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | Recruiting |
+ 27 more sites — see the full list on the official registry below.
More Impulse Dynamics trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05064709 on ClinicalTrials.gov ↗ ← All trials in the USA