Advocate Good Samaritan Hospital in Downers Grove, Illinois, and Aurora St. Luke’s Medical Center in Milwaukee have joined a clinical trial evaluating an investigational device for the treatment of heart failure with a leaking heart valve.
More than 6 million adults in the U.S. have heart failure, according to the U.S. Centers for Disease Control and Prevention, and the American Heart Association estimates that more than 825,000 new heart failure cases are diagnosed annually.
“Heart failure occurs when a person’s heart isn’t pumping blood as well as it should and, therefore, cannot supply enough blood and oxygen to the body’s other organs,” said interventional cardiologist Tanvir Bajwa, MD, study principal investigator for Aurora St. Luke’s, which is the first site in Wisconsin to join the study. “This typically leads to shortness of breath and fatigue, and, left unchecked, it can cause other heart problems and damage other organs.”
Although there is no cure for heart failure, it can be managed with lifestyle changes, medications and sometimes medical devices.
The clinical trial is assessing the safety and effectiveness of the Carillon Mitral Contour System® for the treatment of heart failure that has led to functional mitral regurgitation, which is a mitral heart valve that leaks because the valve opening has become too large and the leaflets cannot fully close.
“In a person with heart failure, we often see the heart become enlarged as it tries to compensate for its inability to pump enough blood,” said interventional cardiologist Mahesh Raju, MD, study principal investigator for Advocate Good Samaritan. “But this can have other negative consequences. For example, the heart’s left ventricle can become so enlarged that the mitral valve, which connects the left atrium and left ventricle, cannot properly close, allowing blood to leak backward with each beat. This causes the heart to try to pump extra blood, creating a cycle that continues to worsen the person’s heart failure.”
The Carillon Mitral Contour System® consists of the Carillon implant device and the device’s delivery system. The device is inserted via a catheter through a small incision and guided using imaging technology through the body’s chain of blood vessels until it is permanently implanted near the mitral valve where it is designed to reduce functional mitral regurgitation.
“Studies show that up to 60% of people with an enlarged heart chamber experience functional mitral regurgitation. And because functional mitral regurgitation leads to a much lower chance of survival, researchers are looking for alternative treatments for people for whom open surgery is too risky and medications are not enough,” said Laura Wrona, MSN, Director of Advocate Aurora Research Institute’s Center of Excellence in Cardiovascular Research. “The Research Institute is proud to support clinical research studies like this that have the potential to directly benefit our patients.”
The clinical trial, “The EMPOWER Trial – Assessment of the Carillon Mitral Contour System® in treating heart failure with functional mitral regurgitation,” is sponsored by Cardiac Dimensions, Inc., manufacturer of the Carillon Mitral Contour System®.
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