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

Brief description of study

The OPTIMIZER Smart Post-Approval Study (PAS) is a single arm open label study of 620 participants receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%.

Detailed description of study

The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that cardiac contractility modulation (CCM) therapy delivered with the Optimizer system improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures. Six minute walk test and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.

Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components:

Optimizer Smart or Optimizer
Smart Mini Vesta Charger or Guardio Charger
Two commercially available intravascular leads

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Heart failure
Age: Between 18 Years - 100 Years
Gender: All

Inclusion

≥ 18 years of age
Left ventricular ejection fraction of 25-45%
NYHA Class III heart failure symptoms
Treated with guideline-directed medical therapy

Exclusion

Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
Myocardial infarction within 90 days prior to implant
Prior heart transplant or ventricular assist device
Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation
Currently participating in a cardiac investigational study at the same time

Updated on 09 Mar 2024. Study ID: 2020-56

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