Why the study?
Functional mitral regurgitation has limited effective treatment options, and long-term safety and effectiveness of the Carillon Mitral Contour System are incompletely characterized.
Does the Carillon Mitral Contour System improve symptoms, reduce mitral regurgitation severity, and prevent heart failure hospitalization or death in patients with symptomatic heart failure and functional mitral regurgitation?
Does the Carillon Mitral Contour System improve symptoms, reduce mitral regurgitation severity, and prevent heart failure hospitalization or death in patients with symptomatic heart failure and functional mitral regurgitation?
The Carillon Mitral Contour System demonstrates sustained reduction in MR severity and stable functional improvements over 5 years with a favorable safety profile in a real-world population with functional mitral regurgitation.
Background: Functional mitral regurgitation (FMR) has limited effective treatment options. As a transcatheter indirect annuloplasty, the Carillon Mitral Contour System reduces FMR and improves symptoms, but long-term safety and effectiveness are incompletely characterized. Methods: This prospective, multicenter CINCH registry enrolled heart failure patients with FMR treated with the Carillon Mitral Contour System across 22 centers in Germany. Main outcomes included change in New York Heart Association (NYHA) class and MR severity, heart failure hospitalization (HFH), all-cause mortality rates, and device- or procedure-related serious adverse events at 1 year. Median follow-up was 2.0 years (range, 0-5 years). Kaplan-Meier estimates over 5 years were 54.0% for HFH, 46.9% for all-cause mortality, and 68.3% for the composite of HFH or death. The proportion of patients experiencing any serious device- or procedure-related serious adverse event at 1 year was 1.8%. Conclusions: The CINCH registry provides real-world evidence supporting the long-term safety, effectiveness, and durability of the Carillon Mitral Contour System in treating FMR.
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Fichtlscherer et al. (2025) studied this question.
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