Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C (FIX-HF-5C)
|NYHA Class III Heart Failure NYHA Class IV Heart Failure||Device: Optimizer System Other: No intervention: Optimal medical therapy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%: FIX-HF-5C|
- Improvement in exercise tolerance [ Time Frame: 24 weeks ]Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX)
- MLWHFQ [ Time Frame: 24 weeks ]Quality of life, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire
- Peak VO2 with respiratory exchange ratio (RER) [ Time Frame: 24 weeks ]Peak VO2 with change in respiratory exchange ratio (RER) included as a covariate.
- NYHA [ Time Frame: 24 weeks ]Heart failure class, as assessed by the New York Heart Association (NYHA) classification.
- peak VO2 with a peak RER of ≥1.05 [ Time Frame: 24 weeks ]Peak VO2 in an analysis that only includes tests with a peak RER of ≥1.05.
- 6 Minute Hall Walk [ Time Frame: 24 weeks ]Distance walked in 6 minutes
- VE/VCO2 [ Time Frame: 24 weeks ]VE/VCO2 as measured during cardiopulmonary stress testing.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Device: Optimizer System
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.
Other Name: CCM therapy
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
Other: No intervention: Optimal medical therapy
The control group receives optimal medical therapy only.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381172
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|Study Director:||Daniel Burkhoff, MD, PhD||Impulse Dynamics|