This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.
Study Type
OBSERVATIONAL
Enrollment
100
Implantation of CoreValve aortic valve via direct aortic approach
Nemocnice Podlesi Trinec
Třinec, Czechia
Hopital de Rangueil
Toulouse, France
Universitätsklinikum Halle (Saale)
Halle, Germany
Azienda spedaliera Spedali Civili Di Brescia
Brescia, Italy
All-cause Mortality
Kaplan-Meier estimate of 30-day all-cause mortality.
Time frame: 30 days post-implant
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
The combined safety endpoint is defined as a composite of: * All-cause mortality * All stroke * Life-threatening bleeding * Acute kidney injury-Stage 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR) * High degree AV block requiring permanent pacemaker implantation
Time frame: 1, 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Azienda spedaliera Niguarda Ca' Granda Milano
Milan, Italy
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch centrum Leeuwarden
Leeuwarden, Netherlands
Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital
Brighton, United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom