Table 7: Current and planned trials Study Primary end point Comparator N Primary Phase Sponsor Valve Clinical trial completion ID date Pilot Trial: Comparison of Comparison of maximum and Regular valve 20 July Medical Edwards Intuity NCT02288871 Flow Patterns minimum velocity, effective 2015 University of valve orifice area, percentage of Vienna turbulent flow, pressure drop between 6 months and 4 years after AVR Perceval S Aortic Heart All-cause mortality 12 months NA 300 January Sorin Group PERCEVAL S NCT01810679 Valve Study- North 2016 USA America Perceval Pivotal Trial Incidence of mortality and NA 150 October 2 and 3 Sorin Group PERCEVAL S NCT00860730 morbidity at 3-6 months after 2009 USA implant CAVALIER Incindence of Incidence of NA 658 October 2 and 3 Sorin Group PERCEVAL S NCT01368666 mortality and morbidity at 12 2014 months Surgical Trauma After Surgical Trauma up to 3 days Minimially 20 December 2 Karolinska Mechanical and NCT02272621 Partial Upper post operaively invasive AVR 2015 University bioprosthetic Hemisternotomy Versus vs Hospital (stented or Full Sternotomy Aortic conventional sutureless) Valve Replacement (RCT) surgery AVR aortic valves Cardiac Function After Cardiac function upto 40 days Minimially 40 July 2 Karolinska Mechanical and NCT01972555 Minimally Invasive Aortic post procedure invasive AVR 2015 University bioprosthetic Valve Implantation vs Hospital (stented or (CMILE) (RCT) conventional sutureless) surgery AVR aortic valves
Table 7: Current and planned trials Study Primary end point Comparator N Primary completion date Phase Sponsor Valve Clinical trial ID Pilot Trial: Comparison of Flow Patterns Comparison of maximum and minimum velocity, effective orifice area, percentage of turbulent flow, pressure drop between 6 months and 4 years after AVR Regular valve 20 July 2015 Medical University of Vienna Edwards Intuity valve NCT02288871 Perceval S Aortic Heart Valve Study- North America All-cause mortality 12 months NA 300 January 2016 Sorin Group USA PERCEVAL S NCT01810679 Perceval Pivotal Trial Incidence of mortality and morbidity at 3-6 months after implant NA 150 October 2009 2 and 3 Sorin Group USA PERCEVAL S NCT00860730 CAVALIER Incindence of Incidence of mortality and morbidity at 12 months NA 658 October 2014 2 and 3 Sorin Group PERCEVAL S NCT01368666 Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement (RCT) Surgical Trauma up to 3 days post operaively Minimially invasive AVR vs conventional surgery AVR 20 December 2015 2 Karolinska University Hospital Mechanical and bioprosthetic (stented or sutureless) aortic valves NCT02272621 Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE) (RCT) Cardiac function upto 40 days post procedure Minimially invasive AVR vs conventional surgery AVR 40 July 2015 2 Karolinska University Hospital Mechanical and bioprosthetic (stented or sutureless) aortic valves NCT01972555
sutureless-aortic-valve-replacement-tier3-assessment.docx