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%
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
• Subjects who are 18 years of age or older
• Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.
• Subjects who, in the opinion of the Investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure.
• Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.
• Subjects who are willing and able to return for all follow-up visits.