Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)

What this Trial Is About

Researchers are evaluating the impact of cardiac contractility modulation (CCM) therapy on mortality and hospitalizations due to heart failure in Medicare-eligible adults with heart failure and reduced ejection fraction who meet indications for CCM. This prospective, multi-center study uses a large electronic health record database with up to 8 years of clinical data from multiple U.S. healthcare systems. The study compares outcomes between patients treated with CCM and a matched control group who did not receive the implant. The study involves two groups: a treatment group receiving the CCM therapy via the Optimizer System implant, and a control group derived through propensity score matching from patients eligible for CCM but who did not get implanted. CCM therapy delivers non-excitatory electrical signals to the heart to improve contraction strength without increasing oxygen consumption. Patients must have NYHA Class III heart failure, an ejection fraction between 25% and 45%, and have remained symptomatic despite at least 3 months of optimized medical therapy before CCM implantation. Participants' data will be followed for up to two years after their index date, tracking time to first heart failure hospitalization or death from any cause. The study uses detailed electronic health records including clinical notes, imaging, lab results, and medication history to monitor outcomes. This observational study helps understand CCM's role in heart failure management by comparing treated patients to similar controls over an extended follow-up period.

Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure