Objectives
Conclusion
Trial Type
Exclusion Criteria
Inclusion Criteria
Population
Trial Method
Endpoints
Endpoint Results
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Test the performance, safety and clinical effects of a 2-lead CCM® device vs a 3-lead CCM® device
Glossary
NHS – National Health Service
NYHA – New York Heart Association
LVEF – Left Ventricular Ejection Fraction SoC – Standard of Care
QALY – Quality Adjusted Life Year:
A measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. ICER – Incremental
Cost-effectiveness Ratio:
Regression equation based cost-effectiveness model that generated predictive values for the following parameters:
PRIMARY EFFICACY
The change of peak VO2 from baseline to 24 weeks was 1.72 (95% Bayesian credible interval [BCI]:1.02,2.42) ml/kg/min greater in the 2-lead device group versus the control group
PRIMARY SAFTEY
Decreased Optimizer®-related adverse events (0% vs 8%, p=0.03) in the 2-lead device group as compared to 3-lead patients in FIX-HF-5C
NYHA improved by at least 1 functional class in 83.1% of subjects treated with the 2-lead Optimizer® system at 24 weeks compared to only 42.7% in the control group
