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A mandated 1-year postmarket study of cardiac contractility modulation (CCM) therapy in 530 HFrEF patients showed a 34% reduction in heart failure hospitalizations, improved functional class in 97% of patients, and meaningful quality-of-life gains. The real-world findings align with earlier trial data, reinforcing CCM's role as a viable device-based option for patients on maximally tolerated guideline-directed medical therapy.
A large, real-world postmarket study of cardiac contractility modulation (CCM) therapy has delivered encouraging results for patients with heart failure with reduced ejection fraction (HFrEF). Presented at the Heart Failure Society of America Annual Scientific Meeting, the FDA-mandated 1-year study enrolled 530 patients across 71 U.S. sites who were already on maximally tolerated guideline-directed medical therapy — including newer agents like SGLT2 inhibitors and ARNIs.
CCM therapy works by delivering electrical signals to the heart during the absolute refractory period via an implanted pulse generator, triggering a biological cascade that improves cardiac contractility. The study found consistent, concordant signals of benefit across multiple endpoints, with no outcomes pointing in the opposite direction.
By the Numbers:
Why it matters: These findings provide the strongest real-world evidence yet supporting CCM therapy's long-term safety and efficacy in HFrEF. For clinicians managing patients who remain symptomatic despite optimal medical therapy, CCM represents a meaningful device-based option backed by a large, contemporary U.S. cohort.