Heart Failure Clinical Trial
— AIM HIGHerOfficial title:
Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction
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 ≤60%.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | February 1, 2026 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 =60% (as assessed by echo core lab); 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, AND elevated BMI-adjusted natriuretic peptide values (Refer to Table A in Section 9.2.6) 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 B in Section 9.2.6) 6. Subjects must be on stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy/intolerance. 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); 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 <20 ml/min/1.73m2; 19. Participating in another investigational study; 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; |
Country | Name | City | State |
---|---|---|---|
United States | Piedmont Healthcare | Atlanta | Georgia |
United States | HCA Florida JFK Hospital | Atlantis | Florida |
United States | Ascension Seton | Austin | Texas |
United States | Austin Heart | Austin | Texas |
United States | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas |
United States | Grandview Medical Group Research, LLC | Birmingham | Alabama |
United States | The University of Alabama at Birmingham | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | St. Louis Heart and Vascular | Bridgeton | Missouri |
United States | Bryn Mawr Medical Specialists Association | Bryn Mawr | Pennsylvania |
United States | Our Lady of Lourdes | Camden | New Jersey |
United States | Sanger Heart and Vascular | Charlotte | North Carolina |
United States | St. Luke's Hospital | Chesterfield | Missouri |
United States | TriHealth Bethesda | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | OhioHealth Research Institute | Columbus | Ohio |
United States | John Muir Health | Concord | California |
United States | Nouvelle Clinical Research LLC | Cutler Bay | Florida |
United States | Baylor Scott and White Research Institute | Dallas | Texas |
United States | HCA Medical City Dallas | Dallas | Texas |
United States | Ascension St. John | Detroit | Michigan |
United States | Hackensack University Medical Center | Edison | New Jersey |
United States | Jersey Shore University Medical Center | Edison | New Jersey |
United States | Northbay Heart and Vascular | Fairfield | California |
United States | Broward Health | Fort Lauderdale | Florida |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Baylor Scott White- All Saints- Fort Worth | Fort Worth | Texas |
United States | Medical City Fort Worth Hospital | Fort Worth | Texas |
United States | The Stern Cardiovascular Foundation | Germantown | Tennessee |
United States | Prisma Health Upstate | Greenville | South Carolina |
United States | Cooper Hospital- Cardiovascular Associates of Delaware Valley | Haddon Heights | New Jersey |
United States | UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania |
United States | Hartford Healthcare | Hartford | Connecticut |
United States | Penn State Hershey Medical City | Hershey | Pennsylvania |
United States | Memorial Healthcare System | Hollywood | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | Houston Methodist | Houston | Texas |
United States | Memorial Hermann Texas Medical Center | Houston | Texas |
United States | Ascension Medical Group St. Vincent | Indianapolis | Indiana |
United States | Franciscan Health Indianapolis | Indianapolis | Indiana |
United States | University of Iowa | Iowa City | Iowa |
United States | St. Lukes Hospital Kansas City (Mid America Heart Institute) | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of California San Diego | La Jolla | California |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | University of Kentucky Research Foundation | Lexington | Kentucky |
United States | Bryan Heart | Lincoln | Nebraska |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | USC Keck School of Medicine | Los Angeles | California |
United States | Catholic Medical Center | Manchester | New Hampshire |
United States | WellStar Health System, Inc | Marietta | Georgia |
United States | Heart Rhythm Specialists | McKinney | Texas |
United States | CardioVascular Associates of Mesa | Mesa | Arizona |
United States | Chan Heart Rhythm Institute | Mesa | Arizona |
United States | Southwest Cardiovascular Associates | Mesa | Arizona |
United States | Baptist Health South Florida | Miami | Florida |
United States | Minneapolis Heart Institute at Abbott Northwestern Hospital | Minneapolis | Minnesota |
United States | Atlantic Health System- Morristown Medical Center | Morristown | New Jersey |
United States | NCA Research Institute - Florida | Naples | Florida |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Weill Cornell Medicine | New York | New York |
United States | Valley Clinical Trials- Foothill Cardiology | Northridge | California |
United States | Valley Clinical Trials- Northridge | Northridge | California |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Revival Clinical Research | Orlando | Florida |
United States | Kansas City Cardiac Arrhythmia Research LLC | Overland Park | Kansas |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Penn Presbyterian Medical Center | Philadelphia | Pennsylvania |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Arizona Heart Rhythm | Phoenix | Arizona |
United States | Banner Health- Phoenix | Phoenix | Arizona |
United States | Cardiovascular Consultants, Ltd | Phoenix | Arizona |
United States | Rutgers New Jersey Medical School | Piscataway | New Jersey |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Baylor Scott and White- The Heart Hospital- Plano | Plano | Texas |
United States | Providence Heart & Vascular | Portland | Oregon |
United States | Tower Health Reading Hospital | Reading | Pennsylvania |
United States | Sequoia Hospital | Redwood City | California |
United States | Baylor Scott and White Research Institute - Round Rock | Round Rock | Texas |
United States | University of California Davis Health | Sacramento | California |
United States | Methodist Hospital | San Antonio | Texas |
United States | University of California, San Francisco | San Francisco | California |
United States | HonorHealth | Scottsdale | Arizona |
United States | Swedish Medical Center | Seattle | Washington |
United States | Ascension Providence Hospital | Southfield | Michigan |
United States | Tallahassee Research Institute | Tallahassee | Florida |
United States | Mercy Health- St. Vincent Medical Center LLC | Toledo | Ohio |
United States | Pima Heart and Vascular | Tucson | Arizona |
United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
United States | North Mississippi Medical Center | Tupelo | Mississippi |
United States | Peace Health | Vancouver | Washington |
United States | MercyOne Iowa Heart | West Des Moines | Iowa |
United States | Cleveland Clinic Foundation - Florida Weston Hospital | Weston | Florida |
United States | Nuvance Health | Wilton | Connecticut |
United States | WellSpan Health | York | Pennsylvania |
United States | Trinity health- Michigan Heart | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Impulse Dynamics |
United States,
Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10. Erratum In: JACC Heart Fail. 2023 Jan;11(1):132. — View Citation
Tschope C, Butler J, Farmakis D, Morley D, Rao I, Filippatos G. Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function. ESC Heart Fail. 2020 Dec;7(6):3531-3535. doi: 10.1002/ehf2.13126. Epub 2020 Dec 3. — View Citation
Tschope C, Van Linthout S, Spillmann F, Klein O, Biewener S, Remppis A, Gutterman D, Linke WA, Pieske B, Hamdani N, Roser M. Cardiac contractility modulation signals improve exercise intolerance and maladaptive regulation of cardiac key proteins for systolic and diastolic function in HFpEF. Int J Cardiol. 2016 Jan 15;203:1061-6. doi: 10.1016/j.ijcard.2015.10.208. Epub 2015 Oct 27. No abstract available. — View Citation
Wiegn P, Chan R, Jost C, Saville BR, Parise H, Prutchi D, Carson PE, Stagg A, Goldsmith RL, Burkhoff D. Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study. Circ Heart Fail. 2020 Apr;13(4):e006512. doi: 10.1161/CIRCHEARTFAILURE.119.006512. Epub 2020 Apr 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months. | Demonstrate that CCM therapy improves functional capacity in subjects with symptomatic heart failure with LVEF =40% and =60%. 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. | 6 months | |
Primary | 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). | 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. | 6 months | |
Primary | Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant | 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. | 12 months | |
Primary | Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS). | 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. | 18 months |
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