St. Louis Heart & Vascular Becomes First Ambulatory Surgery Center in the U.S. to Perform Carillon® Mitral Contour System Procedure as Part of the EMPOWER Trial
St. Louis, MO – St. Louis Heart & Vascular (SLHV) has become the first Ambulatory Surgery Center (ASC) in the United States to perform a procedure using the Carillon® Mitral Contour System as part of the EMPOWER Trial, a national clinical study sponsored by Cardiac Dimensions. The procedure was successfully completed on October 22nd, 2025, marking a milestone moment for heart failure research and patient care.
Led by Dr. Gil Vardi, the study’s principal investigator, SLHV is one of a select number of sites nationwide participating in the EMPOWER Trial, which is evaluating the safety and effectiveness of the Carillon device for patients with heart failure with reduced ejection fraction (HFrEF) and functional mitral regurgitation (FMR).
“This is an exciting advancement for our patients and for heart failure care in the U.S.,” said Dr. Vardi. “The Carillon device offers a novel, minimally invasive way to reshape the heart and improve mitral valve function. To be the first ASC in the nation to perform this procedure is a testament to SLHV’s commitment to innovation and patient-centered care.”
About the EMPOWER Trial
The EMPOWER Trial is a national, randomized, blinded study designed to assess the Carillon Mitral Contour System, a minimally invasive device implanted in the coronary sinus that gently cinches the mitral valve annulus to reduce regurgitation and support positive remodeling of the heart.
Unlike traditional surgical interventions, the Carillon procedure can be performed under conscious sedation in about 45 minutes, providing a new treatment option for eligible patients.
Previous international studies and commercial use in Europe have shown the device’s potential to improve mitral valve function, reverse left ventricular dilation, and enhance patient quality of life. The EMPOWER Trial brings this innovation to U.S. patients in a controlled research setting.
SLHV is currently screening and enrolling eligible patients with dilated cardiomyopathy (LVEF ≤ 50%, LVEDD ≥ 5.7 cm) and functional mitral regurgitation who meet study criteria. Participants remain under the care of their referring physicians while taking part in the trial.
“This study represents hope for patients living with chronic heart failure,” added Dr. Vardi. “It’s a safe, minimally invasive approach that targets the underlying cause of mitral regurgitation, not just the symptoms.”
About St. Louis Heart & Vascular
St. Louis Heart & Vascular (SLHV) is a leading cardiovascular practice providing comprehensive care through advanced diagnostics, innovative procedures, and ongoing research. With a focus on excellence, access, and compassion, SLHV continues to pioneer minimally invasive solutions that improve outcomes and enhance quality of life for patients across the region.
About Cardiac Dimensions
Cardiac Dimensions is a global leader in the development of innovative, minimally invasive treatment options for heart failure and related conditions. The company’s Carillon® Mitral Contour System is designed to address the underlying cause of functional mitral regurgitation and has demonstrated significant improvements in heart structure and function in prior studies.
For more information about the EMPOWER Trial and the Carillon device, visit: www.cardiacdimensions.com
