Effects of CCM-therapy in Patients With Heart Failure

Study Overview
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Brief Summary
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The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with heart failure.

Detailed Description
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The OPTIMIZER III System is indicated for use in patients greater than 18 years of age with symptomatic heart failure due to left ventricular systolic dysfunction despite appropriate medical therapy. The study will gather additional data on the effect of CCM treatment with the objective of determining the impact of CCM on the composite of heart failure hospitalizations and mortality in the low ejection fraction (EF < 35%) and mildly reduced ejection fraction (35 ≤ EF ≤ 45) heart failure population. The study will also assess the impact of CCM on exercise tolerance (six minute hall walk test, 6 Minute Walk Test) and quality of life (Minnesota Living With Heart Failure Questionnaire, MLWHFQ) in these same populations.

Official Title
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Clinical Effects of Cardiac Contractility Modulation (CCM) With the OPTIMIZER III System in Subjects With Heart Failure Caused by Left Ventricular Dysfunction

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (treatment group): Any subject who receives an OPTIMIZER system implant and provides informed consent Exclusion Criteria (treatment group): None Inclusion Criteria (control group): Symptomatic heart failure (NYHA Class 2, 3 or 4) despite receiving optimal medical therapy with doses of medications that are stable (no more than 50 % variation) for at least 7 days. EF ≤ 45% Signed informed consent Exclusion Criteria (control group): Heart failure due to a potentially correctible cause ( e. g. valvular disease, congenital disease) Idiopathic hypertrophic cardiomyopathy, restrictive or constrictive cardiomyopathy, or heart failure on the basis of a known inflammatory or infiltrative disease (e. g. amyloidosis, sarcoidosis) or constrictive disease Active ischemia or exercise tolerance limited by angina Hospitalizations for heart failure which required the use of inotropic support within 14 days of enrollment Chronic (permanent or persistent) atrial fibrillation or atrial flutter Scheduled for a CABG or a PCI procedure, or has undergone a CABG procedure within 90 days or a PCI procedure within 30 days of enrollment Myocardial infarction within 90 days of enrollment Hemodialysis or peritoneal dialysis Prior heart transplant Participating in another study

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic heart failure<br> | |
| CCM treatment<br>Subjects with heart failure receiving OPTIMIZER system implant | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiac mortality |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of all-cause and cardiac-related hospitalizations |  | 24 Months |