Baptist Health Lexington

Kristie Schneider

Principal Investigator

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Aim HIGHer: 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%.

Learn more at clinicaltrials.gov
Eligibility Criteria


  • Signed and dated informed consent form
  • Male or non-pregnant female, 21 years or older
  • Diagnosed with symptomatic heart failure
  • LVEF ≥40 and ≤60% (as assessed by echo core lab)
  • Heart failure hospitalization within 12 months prior to study consent OR Urgent heart failure visit requiring IV therapy during the 6 months prior to study consent
  • Elevated NT-proBNP levels, >200 pg/ml for subjects without atrial tachyarrhythmia (AT) or >600 pg/ml for subjects in AT OR Elevated BNP levels, >75 pg/ml for subjects without AT or >225 pg/ml for subjects in AT
  • 6) Subjects must be on a stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy


  • Resting heart rate <50 or >110 bpm
  • Resting systolic blood pressure <100 or ≥160 mmHg
  • BMI greater than 40
  • Any moderate or severe valvular stenotic disease or any severe valvular regurgitation
  • Mechanical tricuspid valve
  • Complex congenital heart disease
  • 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
  • Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT
  • A KCCQ CCS score higher than 85
  • Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy
  • Unstable angina pectoris within 30 days prior to study consent
  • Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting
  • Receiving cardiac resynchronization therapy (CRT)
  • 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
  • Myocardial infarction within 90 days prior to study consent
  • Prior heart transplant or ventricular assist device
  • Planning to become pregnant during the study
  • Dialysis (permanent) or GFR <20 ml/min/1.73m2
  • Participating in another investigational study
  • 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
  • Expected lifespan of less than 18 months from time of study consent