St. Jude Medical, Inc has completed enrollment of the patients in its multi-center, prospective, European clinical trial to evaluate Trifecta, a stented pericardial tissue heart valve.
The study has enrolled 120 patients at six centers throughout Europe. The trial will be evaluating the safety and efficacy of the Trifecta stented tissue valve as a replacement for the aortic valve that is located between the heart’s left ventricle and the aorta which is the primary vessel carrying blood from the heart to the rest of the body. Efficacy of the valve will be determined by the hemodynamic performance at 12 months, as measured by echocardiography. Hemodynamic performance is characterized by the valve’s ability to allow blood to flow through it in a manner similar to healthy, normal heart valves.
“Completion of European enrollment in the Trifecta study marks an important milestone in our continued efforts to develop additional technologies for patients suffering from debilitating cardiac diseases,” said Frank Callaghan, president of St. Jude Medical’s Cardiovascular Division. “Our investment in the development of this tissue valve demonstrates our dedication to giving physicians the best possible options for treating valvular disease.”