RecruitingNCT07209098

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

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

Sponsor

Impulse Dynamics

Enrollment

4,200 participants

Start Date

Nov 18, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure and Reduced Ejection Fraction NYHA Class III Heart Failure

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at outcomes for heart failure patients who received a device called Cardiac Contractility Modulation (CCM) — which uses electrical pulses to help the heart squeeze more effectively — compared to similar patients who did not receive the device. **You may be eligible if...** - You are 18 or older - You have New York Heart Association (NYHA) Class III heart failure (significant limitations with ordinary activity) - Your heart's pumping function (ejection fraction) is between 25% and 45% - You are not receiving cardiac resynchronization therapy (CRT) - You have been on maximum medical therapy for at least 3 months but still have symptoms **You may NOT be eligible if...** - You have had a heart transplant - You have a mechanical tricuspid heart valve - You have a left ventricular assist device (LVAD) — a mechanical heart pump Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardiac 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.