Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in exercise tolerance quantified by change in ventilatory threshold measured on cardiopulmonary exercise test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Efficacy: Improvement in New York Heart Association (NYHA) Class; improvement in quality of life; change in left ventricular ejection fraction; change in left ventricular end diastolic dimension. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety: all-cause mortality; cardiac mortality; the rate of all-cause hospitalizations; the rate of cardiac-related hospitalizations; overall incidence and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Optimizer System + Optimal medical treatment
Optimizer System implanted and cardiac contractility modulation therapy activated.
|Device: OPTIMIZER System|
|No Intervention: Optimal medical treatment|
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.