CardioFit™ for the Treatment of Heart Failure

Exclusion Criteria

• •1. Presence of an immediately life threatening condition or disease other than heart failure, such as cancer, terminal renal failure etc.
• •2. Acute myocardial Infarction (MI), variant angina pectoris, unstable angina or acute coronary syndrome in the previous three months;
• •3. Previous stroke;
• •4. Coronary Artery Bypass Surgery (CABG) or Percutaneous Coronary Intervention in the past 3 months;
• •5. Episode of NYHA class IV heart failure, including acute pulmonary oedema in the previous three months;
• •6. Heart failure due to acute myocarditis. Restrictive or constrictive pericarditis, haemodynamically significant aortic valve insufficiency aortic stenosis, or mitral valve stenosis;
• •7. Severe renal or hepatic failure (Creatinine level\>3 mg% (265 micromole/liter) or transaminase level four times ULN);
• •8. Diabetes Mellitus treated with insulin for more than two years prior to study entry;
• •9. Diabetic neuropathy;
• •10. Previous neck surgery, including for Peripheral Vascular Disease (PVD), malignancy, and previous irradiation therapy of the neck;
• •11. Current hypotension (systolic blood pressure below 80 mmHg);
• •12. Active peptic disease or history of upper GI bleeding;
• •13. Asthma, severe COPD (e.g. FEV1\<1.5 liter), or severe restrictive lung disease;
• •14. 1st degree AV block with PR interval \> 240msec, 2nd or 3rd degree AV block;
• •15. Atrial fibrillation or flutter in the in the previous 3 months;
• •16. Sustained ventricular tachyarrhythmia with hemodynamic compromise, in the absence of implanted ICD;
• •17. Long QT syndrome, congenital or acquired;
• •18. Recorded or suspected symptomatic vaso-vagal response;
• •19. Treatment by investigational drug or device within the past 3 months;
• •20. Glaucoma, or history of glaucoma;
• •21. Major psychiatric disorder in the present or in the past; Dementia;
• •22. Patients transplanted with tissues or organs;
• •23. Immunosuppressed patients; patients under systemic steroid treatment;
• •24. Anemia with Hb\<10gr/L, unless treated with Epo;
• •25. Patients who are at risk for carotid arteries plaques and have unstable carotid plaques, as assessed by Echo Doppler; and/or patients with \>70% carotid artery stenosis;
• •26. Patient is candidate for cardiac resynchronization device implantation.