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Evaluating the OPTIMIZER Smart device for heart failure treatment

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

Observational Impulse Dynamics · NCT03970343

This study is testing the OPTIMIZER Smart device to see if it can help people with heart failure feel better and improve their quality of life.

Quick facts

Study typeObservational
Enrollment620 (estimated)
Ages18 Years and up
SexAll
SponsorImpulse Dynamics Industry-sponsored
Locations93 sites (Mesa, Arizona and 92 other locations)
Trial IDNCT03970343 on ClinicalTrials.gov

What this trial studies

This observational study assesses the long-term safety and efficacy of the OPTIMIZER Smart device in patients with NYHA class III heart failure symptoms and a left ventricular ejection fraction of 25-45%. It involves a prospective, multi-center, non-randomized, single-arm approach with 620 participants receiving the device as part of their standard care. The study aims to gather real-world data on health outcomes and quality of life improvements associated with the device, building on previous clinical data that demonstrated significant benefits. Participants will be monitored for their compliance with study procedures and overall health improvements over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with NYHA class III heart failure symptoms and a left ventricular ejection fraction between 25-45%.

Not a fit: Patients with primary heart failure due to uncorrected mitral valve disease or those who have undergone recent cardiac procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved quality of life and health outcomes for patients with heart failure.

How similar studies have performed: Previous studies have shown significant improvements in health outcomes with similar cardiac contractility modulation therapies, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient provides written authorization and/or consent per institution and geographical requirements
2. Male or non-pregnant female, aged 18 or older
3. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
4. NYHA Class III heart failure symptoms
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Patient has been treated with guideline-directed medical therapy

Exclusion Criteria:

1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
3. Myocardial infarction within 90 days prior to implant
4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
5. Prior heart transplant or ventricular assist device
6. Mechanical tricuspid valve
7. 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
8. Participating in a cardiac investigational study at the same time
9. 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.

Where this trial is running

Mesa, Arizona and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureOPTIMIZERCCMPost-Approval StudyNYHA class IIIFIX-HF-5CChronic heart failureEjection fraction between 25 and 45
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.