EMPOWER Trial

The EMPOWER Trial is studying the investigational* Carillon Mitral Contour System^® – a minimally invasive therapy designed to treat people with heart failure and any amount of functional mitral regurgitation (commonly known as FMR – a form of mitral valve leakage). The Carillon therapy is intended to not only address the underlying cause of FMR, but also the progression of your heart failure with the potential to improve your survival and quality of life. The EMPOWER Trial is evaluating the ability of the Carillon therapy to do two things:

• Help people feel better in the near-term by improving their FMR
• Help people feel better for the long term by reducing the size of the left ventricle of their heart – called favorable remodeling – to help the heart function better. Favorable remodeling is associated with improved survival, reduced heart failure-related hospitalizations, and enhanced long-term quality of life.^1,2,3

Of interest, this is the first randomized, blinded, sham-controlled mitral repair clinical trial in the U.S. The EMPOWER Trial is also unique in that it that has the following aspects:

• Allows for alternative therapies within the trial, so none of your therapeutic options are sacrificed for trial participation
• At the end of the initial 24-month study period, people in the control group that did not receive Carillon therapy may be eligible to be treated at that time
• The trial is evaluating treatment as an early disease intervention for MR grade I-II, in addition to treating later stage patients with MR grade III-IV

The EMPOWER Trial will be enrolling up to 300 people with heart failure and mild-to-severe FMR (MR grade I-IV) in the U.S. and Europe to assess outcomes.

Study Rationale:

When the mitral valve does not close tightly, causing it to leak, this condition is called mitral regurgitation. Although there are different types of mitral regurgitation, the Carillon therapy is designed to treat functional mitral regurgitation (FMR), also known as secondary mitral regurgitation (SMR). This means that the valve leakage is caused by another condition and is secondary to the original cause. FMR develops as a result of things such as a heart attack or coronary artery disease, where the damaged portion of the heart is no longer able to function properly. This causes the healthy part of the heart to work harder to pump the same amount of blood, enlarging the heart and resulting in heart failure. The enlarged portion of the heart, typically the left ventricle, exerts pressure on the mitral valve, causing it to stretch and preventing it from closing completely, which in turn causes blood to flow backward through the mitral valve. FMR can be compared to a door frame being too big for the doors, resulting in gaps and an incomplete seal.  

                                                                      
Heart failure medication typically helps address FMR symptoms for people with heart failure but may not impact the structural root cause of the disease, which is the enlarged left ventricle. An enlarged ventricle is associated with increased mortality (death), heart failure-related hospitalizations, and a poor long-term quality of life. Device options currently approved by the Food and Drug Administration (FDA) are fairly restrictive, only intended for individuals with moderate-to-severe mitral regurgitation (MR grade III-IV) and do not address the root cause of the FMR.

Signs & Symptoms of FMR:

• Shortness of breath or cough
• Fatigue (feeling tired and worn out)
• Abnormal sounds of the heart heard through a stethoscope
• Heart palpitations or fluttering heartbeat
• Swollen feet or ankles
• Lightheadedness

What is Being Studied? 

The investigational Carillon Mitral Contour System is a minimally invasive therapy – i.e., not a surgical approach. The permanent, investigational Carillon device is placed using a nonsurgical, catheter-based technique in the coronary sinus, a vein on the outside of the heart that is next to the mitral valve. During the procedure, the Carillon device is cinched around the mitral valve. This is designed to do two things: reduce your mitral valve leak, and ultimately, reduce the size of your enlarged left ventricle. This approach is different from any other available treatment and it is intended to both improve your heart failure symptoms as well as the function of your heart over time. The implant procedure usually takes about an hour and is performed in a catheterization lab.

The investigational Carillon therapy has been evaluated in several safety studies, including a blinded, randomized, sham-controlled study, that demonstrated that patients treated with Carillon therapy and heart failure medications may be more likely to have reduced mitral valve leakage and a reduction in left ventricle size than people on standard medical therapy alone.⁴ Carillon therapy has been commercially available in Europe since 2012 and has been used to treat thousands of people worldwide. However, it is an investigational device in the U.S.

In the Carillon procedure:

• No general anesthesia is required
• No additional or changes in medications are needed as a result of the Carillon therapy
• The Carillon device does not interfere with future heart failure treatment options – if required

Thousands of people have been treated with Carillon therapy worldwide

Tampa General Hospital's Sleep Disorders Center provides comprehensive evaluation, diagnosis and ongoing care for adults and children experiencing sleep-related conditions. As one of the largest and most advanced programs in Florida, our center brings together specialists in pulmonology, neurology, otolaryngology (ENT), family medicine and respiratory therapy to deliver coordinated, patient-centered care.

As part of TGH's Ear, Nose & Throat Institute and recognized as one of the first centers in the nation to earn accreditation from the American Academy of Sleep Medicine (AASM), our center remains a leader in sleep medicine. We offer a full spectrum of services—from in-lab and home sleep studies to advanced, minimally invasive therapies—helping patients achieve better sleep and improved overall health. As a high-volume referral center performing hundreds of studies each month, we are trusted by patients and physicians across the region for our expertise, innovation and outcomes.

About Sleep Disorders

Sleep disorders are medical conditions that disrupt normal sleep patterns, affecting both the quality and duration of sleep. Left untreated, these conditions can impact nearly every aspect of health, contributing to fatigue, difficulty concentrating, mood changes and increased risk for serious conditions such as heart disease, stroke and diabetes.

Sleep disorders can take many forms. Some, like insomnia, make it difficult to fall or stay asleep. Others, such as obstructive sleep apnea, cause interruptions in breathing during sleep, reducing oxygen levels and placing strain on the cardiovascular system. Conditions like restless legs syndrome and parasomnias can lead to restless or disrupted sleep, while narcolepsy can cause sudden and uncontrollable sleep episodes during the day.

Because sleep disorders often overlap with other health conditions, accurate diagnosis is essential. At Tampa General, our multispecialty team uses advanced diagnostic tools and clinical expertise to identify the root cause of sleep disturbances and develop personalized treatment plans that restore healthy sleep and improve long-term wellness.

Why Choose TGH's Sleep Disorders Center?

Choosing the right sleep center is essential to getting an accurate diagnosis and effective treatment. Patients choose us for our:

National Recognition

Tampa General Hospital is proud to be recognized on Newsweek's World's Best Hospitals 2026 list because of our commitment to providing compassionate care. Our Sleep Disorders Center is also accredited by the American Academy of Sleep Medicine (AASM), reflecting our commitment to the highest standards in patient care, safety and clinical excellence.

Multispecialty Care Model

Our center is staffed by specialists across pulmonology, neurology, otolaryngology (ENT), family medicine and respiratory therapy, allowing us to care for the full spectrum of sleep disorders. This collaborative approach ensures that every patient benefits from comprehensive evaluation and a coordinated treatment plan tailored to their specific needs.

Accessible Diagnostics and Treatment for Sleep Disorders

Our Sleep Disorders Center is one of the largest of its kind in Florida, offering comprehensive services for both adults and children. Patients have access to a full range of diagnostic options, including in-lab and home sleep studies. This allows for more convenient and timely evaluations. More than half of our sleep studies are conducted at home, reflecting our commitment to accessible, patient-friendly care.

High-Volume Expertise

Tampa General is also a leading referral center, receiving more than 500 study requests each month. Since its inception, our center has performed more than 5,000 home sleep studies in addition to in-lab studies, a volume that translates to expertise unmatched by other sleep centers.

Proactive Screening for Sleep-Disordered Breathing and Snoring

Our team works closely with specialists across the health system, including cardiology, to identify and treat sleep-related conditions that may contribute to broader health concerns such as heart disease. Through proactive screening programs—particularly for obstructive sleep apnea—we help detect conditions earlier and begin treatment sooner, improving outcomes and reducing the risk of complications.

Academic Medicine & Innovation

Innovation is at the core of our program. Our physicians have been at the forefront of developing and advancing new therapies, including implantable devices for sleep apnea. We use many innovative devices, such as Genio® by Nyxoah and remedē implants, but Tampa General was one of the first in Florida to implant the Inspire device and continues to lead in the use of next-generation technologies. We are proud to offer patients more treatment options when traditional therapies are not effective or well tolerated.