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Recruiting Not applicable

Assessment of CCM in HF With Higher Ejection Fraction

NCT05064709 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2022-02-03
Last updated
2026-10-23

Condition(s) studied

Heart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection FractionHeart Failure With Moderately Reduced Ejection FractionDiastolic Heart Failure

Investigational drug(s) / intervention(s)

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini SystemOPTIMIZER™ Smart Mini System

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Signed and dated informed consent form; 2. Male or non-pregnant female, 18 years or older; 3. Diagnosed with symptomatic heart failure; 4. LVEF ≥40 and ≤70% (as assessed by site echo). A historical echo within 60 days of consent may be used for baseline. Ultrafiltration should not be performed within 30 days of echo; 5. Subjects must meet at least one of the four following criteria: I. Heart failure admission (primary or secondary) within 12 months prior to study consent OR heart failure visit requiring IV therapy OR treated with outpatient Furoscix OR intensification of oral diuresis within 6 months prior to study consent II. PCWP \> 15 mmHg up to 6 months prior to consent or within 30 days following consent III. IPAP reading of mean pressure ≥ 22 mmHg in 2 or more readings within 30 days of consent, or 3 or more readings within 60 days across different days, with a sensor implanted ≥ 3 months before first reading IV. Natriuretic peptide value (NTproBNP or BNP) should meet or exceed the value below, depending on the presenting rhythm: * Normal Sinus Rhythm (NSR): NTproBNP (pg/ml) ≥ 150 or BNP (pg/ml) ≥ 50 * Atrial Tachyarrhythmia (AT): NTproBNP (pg/ml) ≥ 450 or BNP (pg/ml) ≥ 150 * Historical natriuretic peptide values within 6 months of consent may be used if subject is in NSR. Subjects in AT on baseline ECG must have natriuretic peptide values collected post-consent. 6. Subjects must meet one of the following conditions: * Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance. Spironolactone used as a diuretic for patients who cannot tolerate oral loop diuretic is an acceptable alternative. * Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event. Exclusion Criteria: 1. Resting ventricular rate \<50 or \>110 bpm; 2. Resting systolic blood pressure \<100 or ≥160 mmHg; 3. BMI greater than 46 4. Any severe valvular stenotic disease or any severe valvular regurgitation; 5. Mechanical tricuspid valve; 6. Complex congenital heart disease; 7. Diagnosis of any of the following conditions that, in the opinion of the investigator, contributes significantly to the primary symptoms of exercise intolerance: angina, significant pulmonary disease, or currently requires 24-hour home oxygen use or scheduled oral steroids, peripheral vascular disease, orthopedic or rheumatologic conditions; 8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT; 9. A KCCQ CCS score higher than 85; 10. Infiltrative/restrictive (e.g., amyloidosis, sarcoidosis, hemochromatosis, Fabry, or radiation-induced heart disease), eccentric LV hypertrophy or inflammatory cardiomyopathy as documented in the medical record; 11. Unstable angina pectoris within 30 days prior to study consent; 12. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher. 13. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; 14. Myocardial infarction within 90 days prior to study consent; 15. Prior heart transplant or ventricular assist device; 16. Planning to become pregnant during the study; 17. Dialysis (permanent) or GFR \<15 ml/min/1.73m2; 18. Participating in another investigational drug or device study that may interfere with the interpretation of study data; 19. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent; 20. Expected lifespan of less than 18 months from time of study consent; 21. Unable to follow through study protocol for any reasons (social support, incarceration, mental illness etc.) in the investigator's judgement. 22. Insurance denial (after all attempts and appeals have been exhausted, and prior-authorization services utilized, if applicable)

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)

FacilityCityRegionStatus
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.

Official registry record

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