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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 and mild FMR treatment.

Recruiting
18 years and older
All
Phase N/A

This study is examining a device called the Carillon Mitral Contour System to help people with heart failure and a condition called functional mitral regurgitation (FMR). FMR is when the heart's mitral valve doesn't close properly, causing blood to leak backward. The study will involve 300 patients from different countries, who will be split into two groups: one group will get the device, and the other will not. Patients will be checked at several times over five years to see how they're doing.

Before joining, patients will need tests like a transthoracic echocardiogram (an ultrasound of the heart) and a coronary angiogram (a special X-ray of the heart's blood vessels). They'll also check the coronary sinus/great cardiac vein to see if the device can be placed.

Here are some key points to consider:

  • The study lasts five years, with regular check-ups at various months.
  • Patients may either receive the Carillon device or have a similar procedure without the device.
  • Participants must have heart failure and meet specific health criteria to join.
Study details
    Functional Mitral Regurgitation
    Heart Failure
    Mitral Valve Insufficiency
    Heart Diseases
    Cardiovascular Diseases
    Heart Valve Diseases

NCT03142152

Cardiac Dimensions, Inc.

9 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

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

Why should I take part in a clinical trial?

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

How long does a clinical trial take place?

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

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

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