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The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Join the EMPOWER Trial for heart failure study with Carillon System.

Recruiting
18 years and older
All
Phase N/A
**The EMPOWER Trial** is a study to see if a special device called the *Carillon Mitral Contour System* can help people with heart failure and a problem called *functional mitral regurgitation (FMR)*. FMR is when the heart's mitral valve doesn't close properly, causing blood to flow backward. The study will have 300 participants from the US, Canada, and Europe. Participants will be split into two groups: one will get the device, and the other will have a similar procedure without the device. **Key Points:** - The study lasts for **five years**, with follow-up visits at 1, 6, 12, 18, and 24 months, and then annually. - Participants must have heart failure with mild FMR and be 18 or older to join. - Participants will be given a **transthoracic echocardiogram** (a heart ultrasound) to see if they qualify. During the study, doctors will check participants' heart health and how well the device works. The study will help decide if this new treatment can improve life for people with this type of heart problem. Participants will be informed about the study's details and must agree to participate and attend all follow-up visits.
Study details
    Functional Mitral Regurgitation
    Heart Failure
    Mitral Valve Insufficiency
    Heart Diseases
    Cardiovascular Diseases
    Heart Valve Diseases

NCT03142152

Cardiac Dimensions, Inc.

11 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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