AMADEUS™ Clinical Study
The AMADEUS study represents the first multi-center trial of the CARILLON® Mitral Contour System™. The AMADEUS study was a 30 patient safety and performance study of the CARILLON Mitral Contour System conducted at six centers located in Germany, Poland, and the Netherlands. The study was designed to assess the safety of the CARILLON Mitral Contour System. AMADEUS enrollment was completed during the second quarter of 2007.
The study met its primary safety endpoint with a low rate of major adverse events ("MAEs") at the 30-day time point. The clinical data indicates statistically significant reductions in all quantitative echocardiographically derived parameters of mitral regurgitation, as well as clinically significant improvements of other key functional parameters including NYHA class, 6 Minute Walk Distances, and Quality of Life.
See the detailed discussions of the AMADEUS study results in the following publications:
TITAN™ Clinical Study
The TITAN study built upon the encouraging results of AMADEUS by extending the
follow-up period, and including a control group. The study was conducted at seven centers located in Germany, Poland, and France and the CARILLON device was implanted in a total of 36 patients. The TITAN study assesses safety and efficacy at 1, 6, 12, 18, and 24 months, as well as at 3, 4, and 5 years. The primary safety endpoint showed an improvement
in the rate of MAEs compared to the AMADEUS study.
As with the AMADEUS trial, the TITAN study also showed an overall reduction in the mitral annulus area. This was associated with a reduction in mitral regurgitation and improvements in other key functional parameters including NYHA class, 6 Minute Walk Distance, and disease specific Quality of Life (using the Kansas City Cardiomyopathy Questionnaire). These improvements are seen acutely as well as through the 12-month timeframe. In addition, at the longer timeframes, these improvements are also associated with reverse remodeling of the left ventricle. The TITAN study is currently in its long-term follow-up phase.
Approximately 70% of the patients in the TITAN study received a permanent implant, and approximately 30% of patients had the device recaptured due to either transient coronary artery compromise, or insufficient functional mitral regurgitation ("FMR") reduction. These non-implanted patients were also assessed and followed up in a manner similar to the implanted patients. They thus provided a non-randomized "control" group.
The TITAN study had a 30-day MAE rate of 1.9% (1/53), indicating a good peri-procedural safety profile. Importantly, there have been no device-related MAEs reported acutely or long-term.
In contrast to the implanted patient population, the pseudo control group showed no change in their mitral regurgitation or other key functional parameters such as 6 Minute Walk Distance, and Quality of Life – despite receiving optimal medical management.
See the detailed discussions of the TITAN study results in the following publication:
The clinical results from the TITAN study show a significant reduction in functional mitral regurgitation. This reduction in FMR is associated with both a reduction in ventricular dimensions (reverse remodeling) as well as clinical improvement in exercise tolerance.
TITAN™ Clinical Study Efficacy Endpoints
