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
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Age: Between 18 Years - 100 Years
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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
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