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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cardiac Contractility Modulation (CCM): CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.

Study summary

The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.

Eligibility

Primary outcome measure(s)

• Time to first heart failure hospitalization or all-cause death — Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.
  Time from index date to the first occurrence of either heart failure-related hospitalization or death in patients with a clinical indication for cardiac contractility modulation (CCM) therapy. Outcomes will be compared between patients implanted with the Optimizer System (treatment arm) and a propensity score-matched control group of patients who are eligible for CCM but did not receive the device. Data will be collected from a large, de-identified, multi-system electronic health record database representing diverse sites of care across the United States.

Trial sites (1)

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