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

Inclusion criteria

• Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
• Diagnosis of heart failure for a minimum of 6 months prior to enrollment
• NYHA Class at time of enrollment, either:

• NYHA Class III or IV - if predominant during the 3-month period prior to enrollment
• NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment and ≥ 1 hospitalization for heart failure during 12-month period prior to enrollment
• LVEF ≤ 40% as measured by echocardiography
• Left ventricle must have appropriate anatomy as measured by Cardiac CT per the VPD Implant sizing criteria described in the device's Instructions For Use
• Eligible for cardiac surgery
• Between 18 and 74 years of age (inclusive)
• Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
• Female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study
• Provide written informed consent
• Agree to the protocol-required follow-up

Exclusion criteria

• Myocardial ischemia requiring PCI or CABG
• Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
• Cardiogenic shock within 72 hours of enrollment
• Revascularization procedure (PCI or CABG) within 60 days of enrollment
• Patient has received a CRT device within 60 days of enrollment
• Patient diagnosed with significant valve disease (AI >1+; MR >2+) which may or may not require surgery
• Patient has received an ICD within 60 days of enrollment
• Patient has received a pacemaker within 60 days of enrollment
• History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
• 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
• Aortic valve replacement or repair
• Resting systolic blood pressure is more than 180 mmHg or less than 90 mmHg
• Resting heart rate more than 120 bpm
• Cardiac CT or echocardiographic evidence of thrombus in the left ventricle or left atrium
• 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)
• GI bleed requiring transfusion within the past 3 months
• Patient has suffered a stroke within the past 6 months
• Evidence of severe calcification in the VPD Implant attachment zone
• Evidence of a significant sub-aortic obstruction ("left moderator band") in the area of implant
• History of Kawasaki's disease
• Patient has received a heart, lung, liver and/or kidney transplant
• Patient on dialysis or expected to require hemodialysis within 12 months
• Patient has chronic liver disease
• Patient has received intracardiac gene therapy or stem cell therapy
• Creatinine > 2.5mg/dl or impaired renal function that places patient at risk of contrast induced renal failure
• Hypersensitivity to contrast media
• Allergy or contraindication to clopidogrel or aspirin
• Evidence of ongoing infection (fever with temperature > 38°C and/or WBC > 15,000)
• 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.)
• Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete