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

Study Overview
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Brief Summary
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The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects 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
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The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully 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, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk 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.

Official Title
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A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care

Conditions
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Heart Failure

Intervention / Treatment
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* Device: OPTIMIZER Smart System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient provides written authorization and/or consent per institution and geographical requirements Male or non-pregnant female, aged 18 or older Left ventricular ejection fraction of 25-45% (inclusive, per site assessment) NYHA Class III heart failure symptoms Stated willingness to comply with all study procedures and availability for the duration of the study Patient has been treated with guideline-directed medical therapy Exclusion Criteria: Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant Myocardial infarction within 90 days prior to implant Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant Prior heart transplant or ventricular assist device Mechanical tricuspid valve Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy Participating in a cardiac investigational study at the same time Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OPTIMIZER Smart System|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of procedure and device-related complications | Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year) | 1 year | 
| All-cause mortality | Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant | 3 years | 
| Procedure related complications | Procedure related complications through the end of 30 days following the index procedure | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular hospitalizations | Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPTIMIZER, Heart Failure, CCM, Post-Approval Study, NYHA class III, FIX-HF-5C, Chronic heart failure, Ejection fraction between 25 and 45, cardiac contractility modulation