Heart Failure, Congestive Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of the OPTIMIZER System With Active Fixation Leads in Subjects With Heart Failure Resulting From Systolic Dysfunction: FIX-HF-5
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
IMPULSE Dynamics' FIX HF 5 US Study is a prospective, multi-center, 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/IV heart failure. The study
will involve the recruitment of approximately 420 subjects at a total of up to 50 sites
nationwide.
Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test
results will be randomized to receive the OPTIMIZER™ System or to a control group. All
subjects randomized will be followed for 1 year and shall receive the same study related
assessments throughout the course of the study. In addition, all subjects will continue to
receive optimal medical therapy for the treatment of their heart failure.
The primary efficacy assessment consists of a change in exercise tolerance measured by
cardiopulmonary exercise testing at baseline and 6 months. Safety variables, such as the rate
and cause of hospitalizations or death, shall be collected in both groups and shall be
compared at 12 months.
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