Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.
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).
ClinicalTrials.gov ID NCT02209298
Sponsor
Primary endpoints
- Primary safety endpoint: Cardiovascular death at 30 days post-index procedure.
- Primary efficacy endpoint: Lack of significant aortic stenosis (defined as mean gradient > 40 mmHg) or insufficiency (defined as > moderate severity) at one year follow-up using clinical evaluation and echocardiography.
CERC Services
- Full Services
Countries
France, Mermany, Israel, Italy
Number of investigational sites
25
Number of patients
200
