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Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

Study on OPTIMIZER Smart device and CCM Therapy benefits.

Recruiting
18 years and older
All
Phase N/A

The **OPTIMIZER Smart Study** is a research project to see if a special device called the **OPTIMIZER** helps people with certain heart problems. This study involves 620 people who already have this device, which is implanted to help their heart function better. The people in the study have a heart condition called **NYHA Class III heart failure** with a **left ventricular ejection fraction** between 25-45%. This means their heart doesn't pump blood as well as it should. The study will check if the device is safe and works well over a long time in real-life conditions.

  • The study is open to men and non-pregnant women aged 18 or older with specific heart conditions.
  • Participants must agree to follow all study steps and be available for the whole study period.
  • If you have other heart issues or treatments, you might not be eligible to join.
Study details
    Heart Failure

NCT03970343

Impulse Dynamics

10 May 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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