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

STUDY OVERVIEW

The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single-arm open-label study sponsored by Impulse Dynamics involving 620 subjects receiving an OPTIMIZER implant as standard of care. Participants with NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45% will be included. This study aims to assess the long-term safety and efficacy of OPTIMIZER Smart in a real-world setting, building on previous clinical data confirming its meaningful health outcomes improvement in patients with heart failure symptoms.

STUDY GOALS

The goal of the OPTIMIZER Smart Post-Approval Study is to evaluate the long-term safety and efficacy of OPTIMIZER Smart implants in patients with NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%, following positive clinical data demonstrating improved health outcomes in this population.

LOCATION

El Paso, Texas: Texas Procedure Center

INCLUSION CRITERIA

  • The patient provides written consent as per the institution's requirements.

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

  • Left ventricular ejection fraction between 25-45%.

  • NYHA Class III heart failure symptoms.

  • Willingness to comply with study procedures and availability for study duration.

  • Previously treated with guideline-directed medical therapy.

exclusion criteria

  • Heart failure is primarily due to untreated mitral valve disease or recent mitral valve intervention.

  • Use of IV inotropes or similar within 30 days before implant.

  • Recent myocardial infarction or cardiac procedures.

  • Previous heart transplant, ventricular assist device, or mechanical tricuspid valve.

  • Currently receiving cardiac resynchronization therapy (CRT) or with a Class I indication for CRT.

  • Concurrent participation in another cardiac study.

  • Belonging to a vulnerable population that may impede informed consent.

Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.

For more information, visit ClinicalTrials.gov.