Objectives
Objectives
Test the performance, safety and clinical effects of a 2-lead CCM® device vs a 3-lead CCM® device.
Conclusions
The 2-lead system effectively delivers comparable amount of CCM® pulses as the 3-lead system, is equally safe and improves peak VO2 and NYHA functional class. Device-related adverse effects are less with the 2-lead system.
Conclusions
Trial Type
TRIAL TYPE
A prospective, multicenter, single-arm study
Population
POPULATION
The control group for this study consisted of the control group in the previous FIX HF-5C study that analyzed the 3-lead Optimizer® system. Baseline peak VO2 and LVEF did not differ significantly between the two groups.
Trial Method
TRIAL METHOD
Endpoints
ENDPOINTS
PRIMARY EFFICACY
Estimated difference in the change of
peak VO2 relative to control subjects
PRIMARY SAFETY
Comparison of device-related adverse events between FIX-HF-5C2 and FIX-HF-5C subjects
Endpoint Results
ENDPOINT RESULTS
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
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