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);
5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)
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.
* 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. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
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. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
11. Unstable angina pectoris within 30 days prior to study consent;
12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
13. 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.
14. 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;
15. Myocardial infarction within 90 days prior to study consent;
16. Prior heart transplant or ventricular assist device;
17. Planning to become pregnant during the study;
18. Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
19. Participating in another investigational drug or device study that may interfere with the interpretation of study data;
20. 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;
21. Expected lifespan of less than 18 months from time of study consent;
22. Unable to follow through study protocol for any reasons in the investigator's judgement.
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 (105)
Facility
City
Region
Status
Grandview Medical Group Research, LLC
Birmingham
Alabama
Recruiting
CardioVascular Associates of Mesa
Mesa
Arizona
Recruiting
Chan Heart Rhythm Institute
Mesa
Arizona
Recruiting
Southwest Cardiovascular Associates
Mesa
Arizona
Recruiting
Arizona Heart Rhythm
Phoenix
Arizona
Recruiting
Cardiovascular Consultants, Ltd
Phoenix
Arizona
Recruiting
HonorHealth
Scottsdale
Arizona
Recruiting
Pima Heart and Vascular
Tuscon
Arizona
Recruiting
John Muir Health
Concord
California
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
University of California Davis Health
Sacramento
California
Withdrawn
University of California, San Francisco
San Francisco
California
Withdrawn
Nuvance Health - Danbury Hospital
Danbury
Connecticut
Recruiting
Hartford Healthcare
Hartford
Connecticut
Recruiting
HCA Florida JFK Hospital
Atlantis
Florida
Recruiting
Nouvelle Clinical Research LLC
Cutler Bay
Florida
Recruiting
Broward Health
Fort Lauderdale
Florida
Recruiting
Memorial Healthcare System
Hollywood
Florida
Withdrawn
Baptist Health South Florida
Miami
Florida
Recruiting
NCA Research Institute - Florida
Naples
Florida
Withdrawn
AdventHealth Orlando
Orlando
Florida
Recruiting
Revival Clinical Research
Orlando
Florida
Recruiting
Tallahassee Research Institute
Tallahassee
Florida
Withdrawn
Cleveland Clinic Foundation - Florida Weston Hospital
Weston
Florida
Recruiting
Piedmont Healthcare
Atlanta
Georgia
Withdrawn
Franciscan Health Indianapolis
Indianapolis
Indiana
Withdrawn
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
Kansas City Cardiac Arrhythmia Research LLC
Overland Park
Kansas
Recruiting
Baptist Health Lexington
Lexington
Kentucky
Recruiting
Ochsner Clinic Foundation
New Orleans
Louisiana
Withdrawn
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
University of Michigan
Ann Arbor
Michigan
Recruiting
Henry Ford St. John Hospital
Detroit
Michigan
Recruiting
+ 65 more sites — see the full list on the official registry below.
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.
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