Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients

Exclusion Criteria

• •1. Myocardial ischemia requiring PCI or CABG
• •2. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
• •3. Cardiogenic shock within 72 hours of enrollment
• •4. Revascularization procedure (PCI or CABG) within 60 days of enrollment
• •5. Patient has received a CRT device within 60 days of enrollment
• •6. Patient diagnosed with significant valve disease (AI \>1+; MR \>2+) which may or may not require surgery
• •7. Patient has received an ICD within 60 days of enrollment
• •8. Patient has received a pacemaker within 60 days of enrollment
• •9. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
• •10. Patients with a history or a current diagnosis of either persistent or paroxysmal atrial fibrillation as well as patients who present with a contraindication to oral anticoagulant therapy
• •11. Aortic valve replacement or repair
• •12. Resting systolic blood pressure is more than 180 mmHg or less than 90 mmHg
• •13. Resting heart rate more than 120 bpm
• •14. Cardiac CT or echocardiographic evidence of thrombus in the left ventricle or left atrium
• •15. History of bleeding diathesis or a major coagulopathy (i.e. platelet count \< 100,000 plts/ml whole blood; PTT or PT \> 1.3 times control value)
• •16. GI bleed requiring transfusion within the past 3 months
• •17. Patient has suffered a stroke within the past 6 months
• •18. Evidence of severe calcification in the VPD Implant attachment zone
• •19. Evidence of a significant sub-aortic obstruction ("left moderator band") in the area of implant
• •20. History of Kawasaki's disease
• •21. Patient has received a heart, lung, liver and/or kidney transplant
• •22. Patient on dialysis or expected to require hemodialysis within 12 months
• •23. Patient has chronic liver disease
• •24. Patient has received intracardiac gene therapy or stem cell therapy
• •25. Creatinine \> 2.5mg/dl or impaired renal function that places patient at risk of contrast induced renal failure
• •26. Hypersensitivity to contrast media
• •27. Allergy or contraindication to clopidogrel or aspirin
• •28. Evidence of ongoing infection (fever with temperature \> 38°C and/or WBC \> 15,000)
• •29. Co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)
• •30. Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete