The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The EMPOWER trial is investigating a new treatment called the Carillon Mitral Contour System for people who have heart failure because one of their heart valves, the mitral valve, isn't closing properly (this is called functional mitral regurgitation). This leaking means the heart has to work harder. The study wants to find out if this new device is safe and effective in treating this problem. Researchers will compare patients who receive the Carillon device with those who receive standard guideline-directed heart failure medication. The study is designed so that neither the patients nor the doctors assessing them will know who has received the device, to ensure fair results. This will help understand if the device can make a real difference for people living with this type of heart failure.
At a glance
What is this study about?
The EMPOWER trial is a significant study focusing on a condition where the heart's mitral valve doesn't close completely, leading to a leaky valve. This leak, known as functional mitral regurgitation, means blood flows backward, making the heart work much harder and often leading to symptoms of heart failure like breathlessness and tiredness. The trial is investigating a new device called the Carillon Mitral Contour System, which aims to help the mitral valve close more effectively.
Imagine your heart as a pump with several doors (valves) that open and close to keep blood flowing in the right direction. If one of these doors, the mitral valve, doesn't shut properly, some blood can leak backward. The Carillon device is designed to gently reshape the area around this valve, helping it close better and reduce the leak. This could potentially ease the strain on the heart and improve a person's quality of life.
This study is carefully designed to be as fair and accurate as possible. It's a 'randomised, double-blinded, sham-controlled' trial. This means that participants are randomly assigned to either receive the Carillon device or undergo a similar procedure without the device (a 'sham' control). Neither the patients nor the healthcare professionals assessing them will know which group they are in. This helps ensure that any improvements or changes observed are genuinely due to the device and not influenced by expectations. The aim is to see if the Carillon system can safely and effectively help people whose heart failure is caused by this specific leaky heart valve issue.
Key takeaways
- The study explores a new device for heart failure caused by a leaky heart valve.
- It aims to check if the Carillon device is safe and improves heart function.
- Participants are randomly assigned to either receive the device or a 'sham' procedure.
- Doctors and patients won't know which treatment was given until after two years.
- Regular follow-up appointments are needed for up to five years.
- This trial could lead to new ways to help people with this specific type of heart problem.
Who may be eligible?
To join this study, you would typically need to be an adult (18 years or older) who is experiencing symptoms of heart failure. Your heart failure should be linked to a leaky mitral valve, known as functional mitral regurgitation. This means your heart valve isn't working as well as it should because of how your heart muscle has changed, not because the valve itself is damaged.
Doctors will also check how severe your heart failure symptoms are and how well your heart is pumping, as well as the size of your heart chambers. There's a specific walking test you'd need to complete, and your blood levels of a particular heart-related substance would also be checked. Importantly, you would need to be receiving the best possible standard medication for your heart failure before joining.
There are also reasons why you might not be able to join. For example, if you've already had certain heart valve surgeries or have other serious heart valve problems that aren't related to the mitral valve leak. If you have other serious health conditions that might shorten your life, or if doctors think you'll need major heart surgery within a year, you wouldn't be suitable for this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have heart failure symptoms linked to a leaky mitral valve (functional mitral regurgitation)?
- Are you currently taking your heart failure medications as prescribed by your doctor?
- Do you not have other serious heart valve problems or need major heart surgery soon?
What does participation involve?
If you decide to take part, you'll first have several tests, including detailed heart scans (like an echocardiogram) and possibly an X-ray of your heart's blood vessels, to ensure the device would fit. If you meet all the requirements, you will then be randomly assigned to one of two groups. One group will receive the Carillon device through a special procedure, while the other group will have a similar procedure but without the device being implanted. This is done so no one knows which treatment they are getting.
After leaving the hospital, your heart specialist and the study team will follow up with you regularly. You'll have check-ups at 1, 6, 12, 18, and 24 months to see how you're feeling and how your heart is doing. After two years, everyone in the study will find out whether they had the device or were in the control group. All participants will then continue to have yearly check-ups for another three years, for a total of five years of follow-up.
Potential risks and benefits
Locations (92)
- Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical CentersVerified postcodeGilbert, United States· Recruiting
- Banner Health - PhoenixVerified postcodePhoenix, United States· Recruiting
- AZ Heart RhythmVerified postcodePhoenix, United States· Withdrawn
- Tucson Medical Center HealthVerified postcodeTucson, United States· Recruiting
- Banner University TusconVerified postcodeTucson, United States· Recruiting
- Memorial Care HospitalVerified postcodeLong Beach, United States· Terminated
- Keck School of Medicine of USCVerified postcodeLos Angeles, United States· Recruiting
- UCLA Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- Stanford UniversityVerified postcodeRedwood City, United States· Recruiting
- Scripps HealthVerified postcodeSan Diego, United States· Recruiting
- University of California- San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- South Denver CardiologyVerified postcodeLittleton, United States· Recruiting
Common questions
What is 'functional mitral regurgitation'?
It means your heart's mitral valve doesn't close properly, causing blood to leak backward, usually because your heart has become enlarged or damaged due to conditions like heart failure.
What is the Carillon Mitral Contour System?
It's a small device designed to help your leaky mitral valve close better, which could reduce the strain on your heart caused by the blood leaking backward.
Why don't patients know if they got the device?
This 'blinding' ensures that the study results are fair and aren't influenced by whether a patient knows if they received the actual device or not.
How long will I be followed in the study?
You will have regular check-ups for two years, and then yearly contact for another three years, making it a total of five years.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any point without it affecting your medical care.
How to find out more
Hank Hauser
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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