OPTIMIZER Smart for Heart Failure

(PAS Trial)

Not currently recruiting at 100 trial locations

Overseen By Anthony Hong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Impulse Dynamics

Must be taking: Guideline-directed therapy

Must not be taking: IV inotropes

Disqualifiers: Mitral valve disease, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the OPTIMIZER Smart device, which helps manage heart failure symptoms in patients with a specific heart condition. The research targets individuals with moderate heart failure symptoms and a left ventricular ejection fraction between 25-45%. Those who experience symptoms like breathlessness or fatigue due to heart failure, despite medication, might be suitable candidates. The trial will monitor the device's effectiveness and safety for those receiving it as part of their regular care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients should have been treated with guideline-directed medical therapy, which suggests you may need to continue your current treatment.

What prior data suggests that the OPTIMIZER Smart implant is safe for patients with NYHA functional class III symptoms?

Research has shown that the OPTIMIZER Smart System is generally safe, as previous studies have indicated. Most patients have tolerated the device well. Some studies found it safe and effective for individuals with heart failure. The FDA has already approved the OPTIMIZER Smart for heart failure, confirming it has passed strict safety tests.

Several clinical studies have tested the device and found no major safety issues. Additionally, the OPTIMIZER Smart is compatible with MRI (magnetic resonance imaging) scans, allowing patients to undergo certain imaging tests without concern. While all medical treatments carry some risks, most patients have tolerated the OPTIMIZER Smart well. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The OPTIMIZER Smart is unique because it uses Cardiac Contractility Modulation (CCM) therapy, which is a new approach for treating heart failure. Unlike standard treatments that typically focus on managing symptoms or improving heart pumping efficiency through drugs or devices like pacemakers, CCM therapy directly enhances the heart's natural contraction by sending electrical signals to the heart muscle during its natural beating cycle. Researchers are excited about this treatment because it has the potential to improve heart function and quality of life in patients who are not adequately managed by current options.

What evidence suggests that the OPTIMIZER Smart is effective for NYHA functional class III symptoms?

Research shows that the OPTIMIZER Smart device can improve heart function in people with certain heart conditions. Studies have found that patients can walk farther in six minutes, experience better daily living, and see overall health improvements. After receiving the OPTIMIZER implant, many patients notice steady improvements for up to 24 months. The device enhances the heart's pumping efficiency, leading to better daily activities and symptom relief. This treatment is approved for specific heart conditions and is supported by strong clinical evidence. ^{1 2 3 6 7}

Who Is on the Research Team?

Rami Kahwash, MD

Principal Investigator

Ohio State University

Raul Weiss, MD

Principal Investigator

Mt. Sinai Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

Left ventricular ejection fraction of 25-45% (inclusive)

Patient provides written authorization and/or consent per institution and geographical requirements

Male or non-pregnant female, aged 18 or older

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the OPTIMIZER Smart implant and CCM therapy as standard of care

1 year

Regular follow-up visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Periodic follow-up visits to assess cardiovascular and heart failure hospitalization rates

Long-term follow-up

Participants are monitored for all-cause mortality and device-related complications

3 years

What Are the Treatments Tested in This Trial?

Interventions

• OPTIMIZER Smart

Who Is Running the Clinical Trial?

Impulse Dynamics

Lead Sponsor

Trials

14

Recruited

3,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8360159/

Long‐term clinical experience with cardiac contractility ... Data show consistent improvements in all effectiveness measures for all groups over the 24 months of follow‐up after Optimizer implant. Similarly, functional ...

2. impulse-dynamics.com impulse-dynamics.com/wp-content/uploads/2021/04/2019-Campbell-OSU-Optimizer-Smart-Device-Evaluation-with-Disclaimer.pdf

2019-Campbell-OSU-Optimizer-Smart-Device- ... The OPTIMIZER Smart System, which delivers CCM™ therapy, is indicated to improve 6-minute hall walk distance, quality of life and functional status of NYHA ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03970343

Post Approval Study (PAS) of the OPTIMIZER Smart and ... 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 ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180036b.pdf

summary of safety and effectiveness data (ssed) The applicant will conduct a post-approval study (PAS) to provide long term safety and effectiveness data for the OPTIMIZER Smart System.

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.119.006512

Safety, Performance, and Efficacy of Cardiac Contractility ... The present results demonstrate that compared with the prior 3-lead system, the 2-lead Optimizer Smart device delivers equivalent amounts of CCM ...

6. impulsedynamics.it impulsedynamics.it/wp-content/uploads/2020/05/13-250-003-01-US-Rev-01-OPT-Smart-System-Patient-Manual.pdf

OPTIMIZER® Smart System - Impulse Dynamics Improving the inherent safety of the OPTIMIZER Smart will allow physicians to expand its use thereby helping more patients with chronic heart failure. This ...

7. impulse-dynamics.com impulse-dynamics.com/opt-smart-leads-information/

opt smart leads information The OPTIMIZER Smart IPG is Magnetic Resonance (MR) Conditional, and patients with this device may be scanned safely with magnetic resonance imaging (MRI).