Overview

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%.

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;