FIX-HF-5CA: Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects with Moderate-to-Severe Heart Failure with Ejection Fraction between 25% and 45%

Two previous protocols (FIX-HF-5 and FIX-HF-5C) under IDE G0300099 have been conducted to evaluate the safety and efficacy of the Optimizer System with CCM (cardiac contractility modulation) therapy. The FIX-HF-5CA protocol allows ongoing access to CCM patients suffering from moderate to severe heart failure at selected investigational sites until the PMA order has been issued by the FDA for the OPTIMIZER System. All enrolled subjects who meet the eligibility criteria will be implanted with the device. Inclusion Criteria: 1. Male and nonpregnant females who are 18 years of age or older; 2. LVEF 25-45% (inclusive, per site assessment); 3. Optimal and stable heart failure medications; 4. NYHA III or IV

You may be eligible for this study if you meet the following criteria:

• Conditions:
  heart failure
• Age: - 99 Years
• Gender: All