ENHANCE Early Feasibility Study Looks to Treat Functional Mitral Regurgitation
CINCINNATI (August 17, 2026) – The Christ Hospital Health Network has enrolled its first patient in the ENHANCE Early Feasibility Study. This multicenter clinical trial evaluates the investigational CARLEN System, a novel transcatheter technology designed to treat patients with symptomatic functional mitral regurgitation (FMR). The structural heart team enrolled the second patient in the United States.
The study at The Christ Hospital is led by principal investigator Puvi Seshiah, MD, interventional cardiologist and co-investigator Santiago Garcia, MD, director of the Structural Heart Program. FMR occurs when the mitral valve does not close properly, allowing blood to flow backward through the heart and contributing to symptoms such as shortness of breath, fatigue and worsening heart failure.
"We are thrilled to be one of the first sites to take part in this study,” said Dr. Seshiah. “This reflects the strength of our structural heart program and our commitment to advancing the next generation of minimally invasive valve therapies. Clinical trials like ENHANCE EFS allow us to do everything it takes to contribute to the development of innovative technologies while providing eligible patients with access to investigational treatment options that may not be available."
The CARLEN System is designed to support the patient’s existing mitral valve, helping it close properly while preserving its natural motion and function. It is delivered through a minimally invasive transcatheter approach. This clinical trial is made possible through The Carl and Edyth Lindner Center for Research and Education.
“Functional mitral regurgitation can be difficult to treat, particularly for patients whose symptoms persist despite medical therapy,” said Dr. Garcia. “The ENHANCE study allows us to evaluate a new approach designed to support the patient’s existing mitral valve while preserving its natural motion and function. We are proud to help advance research that may expand treatment options for patients in the future.”
The CARLEN System is an investigational device and is not approved for commercial use in any geography.
About The Christ Hospital Health Network
The Christ Hospital Health Network consists of an acute care hospital located in Mt. Auburn, a remote hospital location in Liberty Township, five ambulatory outpatient centers and dozens of medical offices throughout the region. For 137 years, The Christ Hospital has provided compassionate care to those it serves. Made up of more than 1,300 physicians and more than 7,600 team members, our mission is to improve the health of our community by providing exceptional outcomes in an affordable way. The Network was recognized by U.S. News & World Report as the #3 hospital in Ohio and named to Newsweek’s World’s Best Hospitals list in 2026.
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