Assessment of CCM in HF With Higher Ejection Fraction

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.