Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (PAS)

STUDY OVERVIEW

The OPTIMIZER Smart Post-Approval Study sponsored by Impulse Dynamics is a prospective, multi-center, open-label study with 620 subjects who receive the OPTIMIZER implant as standard care. It focuses on patients with NYHA class III heart failure symptoms and a left ventricular ejection fraction of 25-45%. Previous studies showed that Cardiac contractility modulation (CCM) therapy with the OPTIMIZER significantly improved health outcomes and quality of life. This study aims to assess the long-term safety and effectiveness of the OPTIMIZER Smart in real-world conditions.

STUDY GOALS

The goal of this study is to evaluate the long-term safety and efficacy of the OPTIMIZER Smart device in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%, building on previous clinical data that showed significant improvements in health outcomes and quality of life with CCM therapy.

LOCATION

El Paso, Texas: Texas Procedure Center

INCLUSION CRITERIA

  • Written authorization/consent provided.

  • Male or non-pregnant female, 18 years or older.

  • Left ventricular ejection fraction of 25-45%.

  • NYHA Class III heart failure symptoms.

  • Willing to comply with study procedures and available for the study duration.

  • Treated with guideline-directed medical therapy.

exclusion criteria

  • Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair/clip within 90 days.

  • IV inotropes, hemofiltration, or positive inotropic support within 30 days.

  • Myocardial infarction within 90 days.

  • CABG procedure within 90 days or PTCA within 30 days.

  • Prior heart transplant or ventricular assist device.

  • Mechanical tricuspid valve.

  • Receiving or indicated for cardiac resynchronization therapy (CRT).

  • Participating in another cardiac investigational study.

  • Vulnerable populations (e.g., significant mental disability, prisoners) that impede informed consent.

For more information, visit ClinicalTrials.gov.