The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.
The Impulse Dynamics FIX-HF-5C Study is a prospective, multicenter, randomized study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER System in patients with NYHA class III and IV heart failure and an ejection fraction 25-45%. The study will involve the recruitment of 160 subjects at a total of up to 60 sites. Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomly assigned in a 1:1 ratio to either the OPTIMIZER System plus optimal medical therapy (OMT) or to a control group receiving OMT alone. All randomized subjects will be followed for 24 weeks and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive OMT for the treatment of their heart failure. Mortality will be reported out to 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
The control group receives optimal medical therapy only.
Peak VO2
Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX) and evaluated by a blinded core lab.
Time frame: 24 weeks
Minnesota Living With Heart Failure (MLWHF) Questionnaire
Change in quality of life at 24 weeks compared to baseline, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The MLWHFQ score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of lif
Time frame: 24 weeks
Peak VO2 With Respiratory Exchange Ratio (RER)
Peak VO2 with change in respiratory exchange ratio (RER) included as a covariate, as measured by a blinded core lab.
Time frame: 24 weeks
NYHA
Heart failure class, as assessed by the New York Heart Association (NYHA) classification.
Time frame: 24 weeks
Peak VO2 With a Peak RER of ≥1.05
Peak VO2 in an analysis that only includes tests with a peak RER of ≥1.05.
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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