The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study. Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Transcatheter Aortic Valve
University of Alberta Hospital
Edmonton, Canada
Institut de Cardiologie de Montreal
Montreal, Canada
University of Ottawa Heart Institute
Ottawa, Canada
Herzzentrum Leipzig GmbH
Leipzig, Germany
HELIOS Heart Center Siegburg
Siegburg, Germany
Amphia Hospital
Breda, Netherlands
Erasmus MC
Rotterdam, Netherlands
Glenfield Hospital
Leicester, United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom
Composite Major Adverse Event (MAE) Free Rate
Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.
Time frame: 30 (+7) days post procedure
Composite Technical Device Success
Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction. The four measures of the ''Device Functionality Assessment'' were: * Load the valve delivery system using the loading system * Access the aortic valve with the delivery catheter * Deploy the valve accurately across the native aortic valve * Remove the intact delivery system
Time frame: Was assessed during the procedure and completed once the procedure was conlcluded
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