NCT07209098

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,200 (estimated)
• Sponsor: Impulse Dynamics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure and Reduced Ejection Fraction
• NYHA Class III Heart Failure

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-11-18
• Primary completion: 2030-10-01
• Completion: 2031-04-01
• First posted: 2025-10-06
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study