Heart Failure - Aim Higher

The purpose of this study is to determine whether CCM® treatment will reduce the occurrence of cardiovascular mortality and heart failure hospitalizations in patients with an ejection fraction (the measurement of the heart's efficiency to pump out blood) greater than or equal to 40% and less than or equal to 60%. While the OPTIMIZER® system is approved for use in HFrEF patients, it is considered investigational for patients with an ejection fraction greater than 45% in the US. "Investigational" means that the study device is currently being tested. It is not approved by the FDA for use in patients with an ejection fraction greater than 45%.

Criteria:
Inclusion:

  1. Signed and dated informed consent form;
  2. Male or non-pregnant female, 21 years or older;
  3. Diagnosed with symptomatic heart failure;
  4. LVEF ≥40 and <60% (as assessed by echo core lab)
  5. 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;
  6. Elevated NT-proBNP levels, >200 pg/ml for subjects without atrial tachyarrhythmia (AT) or > 600pg/ml for subjects in AT (at screening) OR Elevated BNP levels, > 75 pg/ml for subjects without atrial tachyarrhythmia (AT) or > 225 pg/ml for subjects in AT (at screening);
  7. 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.
    Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days.

Exclusion:

  1. Resting heart rate <50 or >110 bpm;
  2. Resting systolic blood pressure <100 or >160 mmHg;
  3. BMI greater than 40
  4. Any moderate or severe valvular stenotic disease or any severe valvular regurgitation;
  5. Mechanical tricuspid valve;
  6. Complex congenital heart disease (e.g. atrial septal defects < 1cm are acceptable);
  7. Exercise tolerance limited by a condition other than heart failure (e.g., angina, significant pulmonary disease, or currently requires home oxygen or oral steroids, peripheral vascular disease, orthopedic or rheumatologic conditions) that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
    Note: Subjects undergoing CPET baseline testing (at sites participating in the CPET sub-study) who are unable to complete an adequate test may still be eligible, as long as their exercise tolerance is not limited during the 6MWT. Subjects must be able to ambulate without orthopedic prothesis or assistance.
  8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
  9. A KCCQ CSS score higher than 85;
  10. Hypertrophic, infiltrative/restrictive (e.g., amyloidosis, sarcoidosis, hemochromatosis, Fabry, or radiation-induced heart disease), or inflammatory cardiomyopathy as documented in the medical record;
    Note: Refer to Section 9.4.1. Screening Evaluation and Baseline Visit for guidance on amyloidosis screening.
  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;
    Note: Patients may be participating in registry/observational studies.
  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 (social support, distance from research center, mental illness etc.) in the investigator's judgement.
    Note: Concomitant devices involving intracardiac leads, if required, should be implanted a minimum of either 31 days prior to or 31 days after the Optimizer implant procedure.

Location(s): Hartford Hospital, Backus, Midstate

Contact(s): Jennifer Rossi, 8609725311, [email protected]