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

Sponsored by Impulse Dynamics

About this study

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.

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.

Where this study is enrolling

Who can participate

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).

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.