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Research & Innovation

OPTIMIZER SMART POST-APPROVAL STUDY

Clinical Trials

OPTIMIZER SMART POST-APPROVAL STUDY

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

Physician & Study Coordinator

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Synopsis

Synopsis: The purpose of this research is to evaluate the safety of long-term use of the OPTIMIZER Smart and CCM therapy. The PAS will also evaluate the effects of CCM therapy on your quality of life and heart failure symptoms, as well as your heart’s ability to pump effectively (echo) and some potential blood related chemical changes.

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Eligibility Criteria

Inclusion Criteria

  • Male or non-pregnant female, aged 18 or older
  • NYHA Class III heart failure symptoms

Exclusion Criteria

  • Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry disease, cardiac tumor)
  • Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days prior to implant
  • IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant, including continuous IV inotrope therapy
  • Myocardial infarction within 90 days prior to implant
  • Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days prior to 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
  • Currently on dialysis
  • Currently undergoing treatment for cancer

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