This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
To collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.
Study Type
OBSERVATIONAL
Enrollment
202
Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.
CHU Brest
Brest, France
CHU Clermont
Clermont-Ferrand, France
Cardiovascular death
Time frame: 30 days post-index procedure
Lack of significant aortic stenosis or insufficiency
Time frame: 1 year Follow-up
Safety composite endpoint based on VARC-II endpoint definitions
Time frame: At 30 days and during follow-up visits
Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient
Time frame: At 30 days and during follow-up visits
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CHU Mondor
Créteil, France
Clinique Parly 2 Le Chesnay
Le Chesnay, France
CHU Lille
Lille, France
HCL CHU Louis Pradel
Lyon, France
CHU La Timone
Marseille, France
Hopital Jacques Cartier
Massy, France
CHU de Nantes
Nantes, France
CHU La Pitié Salpétrière
Paris, France
...and 15 more locations