Research Study: OPTIMIZER PAS
Condition:
Heart Failure
Study Sponsor:
Impulse Dynamics
Study Investigator:
Dr. Jay Sengupta
Study Contact:
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:
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%
Eligibility Criteria:
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.
