Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (PAS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
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%
Condition or disease
Device: OPTIMIZER Smart System
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.
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)
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
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.