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

Study Overview
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Brief Summary
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The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.

Official Title
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A Feasibility Trial to Evaluate the VPD Implant System - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Conditions
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Heart Failure

Intervention / Treatment
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* Device: VPD Implant System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VPD Implant System|Percutaneous introduction using standard catheterization techniques of the VPD Implant.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety defined as the successful delivery and deployment of the VPD Implant through 6 month follow up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary Effectiveness Measurements at 6 months - Change in LV volume indices (LVESVI, LVEDVI, EF) - Change in 6 minute walk and VO2 max - Cardiovascular mortality and morbidity inclusive of hospitalization for HF, MI and stroke |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, percutaneous, interventional cardiology, apical remodeling, LV dilatation, akinesis, dyskinesis