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Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Sponsor: Impulse Dynamics
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.
Official title: Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
4200
Start Date
2025-11-18
Completion Date
2031-04
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
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.
Locations (1)
Impulse Dynamics
Marlton, New Jersey, United States