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Assessment of CCM in HF with Higher Ejection Fraction

Studying heart device effects in patients with better heart function.

Recruiting
18 years and older
All
Phase N/A

The AIM HIGHer Clinical Trial is checking if a new heart therapy called **Cardiac Contractility Modulation (CCM)** helps people with heart failure. Heart failure happens when the heart doesn't pump blood well. In this trial, they are using a special device called the **Optimizer System** to help the heart pump better. The trial is for adults with a certain heart strength, called **Left Ventricular Ejection Fraction (LVEF)**, between 40% and 60%. About 150 locations in the US and 75 outside the US will participate.

Participants will be divided into two groups: one where the CCM is turned on and another where it's off. This will last for 18 months. After that, those who had the CCM off will get it turned on. This trial will help determine if CCM is safe and effective based on how well people can do physical activities and their overall health.

  • **Duration:** The study lasts 18 months.
  • **Visits:** Participants must attend regular health check-ups.
  • **Compensation:** Varies by location; discuss with your doctor.

To join, you need to be 18 or older, have heart failure, and meet other health criteria. Some people cannot join, like those with certain heart conditions or other health issues. Talk to your doctor to see if you qualify.

Study details
    Heart Failure
    Heart Failure with Preserved Ejection Fraction
    Heart Failure with Mid Range Ejection Fraction
    Heart Failure with Moderately Reduced Ejection Fraction
    Diastolic Heart Failure

NCT05064709

Impulse Dynamics

1 February 2025

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Learn more about clinical trials

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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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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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