The Heart Center team participates various multicenter International randomized trials. The main focus of the research is percutaneous treatment of mitral regurgitation. After completing the initial phase of RESHAPE HF-2 trial having recruited 105 patients, the team has initiated the CARILLON pivotal trial randomizing patients with functional mitral regurgitation and heart failure to conservative medical treatment vs implantation of CARILLON device.
The heart team of Heart Center which is based in the European Interbalkan Medical Center in Thessaloniki is currently the only institution in Greece that participates in this trial. Recruitment in participation of patients in the trial is totally free of charge.
Currently the heart center team are currently the top recruiters internationally for this trial having already recruited 15 patients.
The Carillon implantation aims to reduce functional mitral regurgitation in patients with heart failure. The aim of the trial is to look for hard and points such as reduction in mortality and hospitalization in these patients. Carillon device is currently CE Mark approved and globally over 1,000 procedures have been performed with good results.
The screening data of the patients are sent to the Cleveland clinic Echo core lab and after approval the patients are randomized to eitherreceiving the device versus continuing on medical treatment. The patients are being followed up for a period of 5 years by the Heart Center team.