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

NCT07209098 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4200

Last updated 2026-03-24

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-18
Primary Completion
2030-10-31
Completion
2031-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209098 on ClinicalTrials.gov