Patients Physicians Studies Publications News Company Contact Media Kit Active and Completed Studies Promising Results to Help Reshape the Treatment Pathway for Patients The Carillon Therapy has been evaluated in four prior studies. The most recently completed study was a blinded, randomized, sham-controlled study which demonstrated that patients implanted with the Carillon Therapy and coupled with medical therapy were more likely to have reduced mitral regurgitation and experience a reduction in left ventricle size as compared to patients who were treated with medical therapy alone. The Carillon Therapy has been commercially available in Europe since 2011 with more than 1,500 patients receiving the Carillon Therapy worldwide. We are currently enrolling patients in the U.S. pivotal EMPOWER Trial. The goal of this trial is to show the Carillon Therapy can be used earlier in a patient’s disease state and will ultimately lead to a new option to treat patients before their disease progresses and the damage becomes irreversible. Talk to your doctor to see if this trial is right for you. For Further Information FIND AN EMPOWER SITE DOWNLOAD BROCHURE Completed Studies REDUCE FMR JACC: Heart Failure doi: 10.1016/j.jchf.2019.06.011 The REDUCE FMR Trial was the first double-blinded, randomized, sham-controlled trial of a percutaneous heart valve therapy. The REDUCE FMR Trial achieved its primary endpoint of reduction in regurgitant volume (RV) and demonstrated favorable left ventricular (LV) remodeling. A median 22% reduction in regurgitant volume was demonstrated, as assessed by a blinded, independent echo core lab. In addition, an improvement of almost 17ml versus the control group was shown in favorable left ventricular remodeling. The results of The REDUCE FMR Trial are consistent with the prior Carillon Therapy studies. Read more... TITAN II Open Heart doi: 10.1136/openhrt-2016-000411 The TITAN II study achieved its endpoint and showed significant improvements in echo parameters and patient function. TITAN II was a single-arm study designed to assess the safety and efficacy of an updated version of the Carillon Therapy. Inclusion and exclusion criteria were similar to those in TITAN. Patients had symptomatic congestive heart failure (NYHA class ≥2), MR grade 2+ to 4+, a dilated LV (LVEDD >55 mm) and an ejection fraction <40%. Quantitative assessments of MR were performed by an independent core echo laboratory, and MAE were reviewed by an independent data and safety monitoring board. In total, 36 patients were enrolled; 30 received a permanent implant. Read more... TITAN European Journal of Heart Failure doi:10.1093/eurjhf/hfs076 The TITAN study met its endpoint and showed the Carillon Therapy can significantly and safely reduce FMR severity in heart failure patients, resulting in significantly favorable LV remodeling over 12 months and improved measures of clinical outcomes over 24 months. Read more... AMADEUS Circulation doi: 10.1161/CIRCULATIONAHA.109.849885 The first-in-human AMADEUS study met its endpoint and demonstrated successful deployment of the Carillon Therapy and a significant reduction in FMR. AMADEUS was a single-arm, first-in-human study designed to evaluate the safety and feasibility of the Carillon Therapy. The study utilized several independent bodies to minimize bias and increase rigor, including a blinded independent echo core lab, clinical events committee, and data and safety monitoring board. Key inclusion criteria included moderate to severe FMR, NYHA class II-IV, LVEDD >55mm, and ejection fraction <40% receiving sustained stable and optimal HF medication regimen. The study enrolled 48 patients with the device successfully implanted in 30 patients. At six months, the degree of FMR reduction among five different quantitative echo measures ranged from 22-32%. Read more... Join our mailing list for invitations to studies along with company announcements. © 2021 Cardiac Dimensions. All rights reserved. Terms of Use | Privacy Policy | Legal Notice | Intellectual Property | Impressum NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark. CAUTION: Investigational Device. Limited by United States law to investigational use. Patients Physicians Studies Publications News Company Contact Media Kit