NCT07209098Recruiting

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

Impulse Dynamics

Start Date

11/18/2025

Completion Date

4/1/2031

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.

Detailed Description

Data for both the CCM treatment arm and a propensity-matched control group come from a large, de-identified, aggregated electronic health record (EHR) database containing patient information from multiple U.S. healthcare systems. The database includes demographics, clinical notes, imaging, laboratory results, medications, social determinants of health, and other relevant healthcare information, with up to 8 years of historical clinical data updated regularly.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria 1. Continuous representation in the database in the year prior to index. 2. Age 18 or older will be enrolled in either the treatment or control arm of the study. 3. NYHA III heart failure, 4. Not receiving CRT 5. EF 25 - 45%, inclusive. 6. Remain symptomatic despite at least 3 months of optimized guideline-directed medical therapy (GDMT) as determined by the heart team prior to CCM implantation. Exclusion Criteria 1. Subject has had a prior heart transplant 2. Subject with mechanical tricuspid valve. 3. Subject has a left ventricular assist device (LVAD).

Interventions

DEVICE

Cardiac Contractility Modulation (CCM)

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Conditions

Heart Failure and Reduced Ejection FractionNYHA Class III Heart Failure

Locations

Impulse Dynamics

Marlton, New Jersey 08053

United States