Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C (FIX-HF-5C)
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|ClinicalTrials.gov Identifier: NCT01381172|
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : September 17, 2021
Last Update Posted : September 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|NYHA Class III Heart Failure NYHA Class IV Heart Failure||Device: Optimizer System Other: No intervention: Optimal medical therapy||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 19, 2019|
|Actual Study Completion Date :||March 19, 2019|
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.
- Peak VO2 [ Time Frame: 24 weeks ]Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX) and evaluated by a blinded core lab.
- Minnesota Living With Heart Failure (MLWHF) Questionnaire [ Time Frame: 24 weeks ]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
- Peak VO2 With Respiratory Exchange Ratio (RER) [ Time Frame: 24 weeks ]Peak VO2 with change in respiratory exchange ratio (RER) included as a covariate, as measured by a blinded core lab.
- 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 measured during cardiopulmonary stress testing (CPX) and evaluated by a blinded core lab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381172
|Study Director:||Daniel Burkhoff, MD, PhD||Impulse Dynamics|