Presentation during the EuroPCR 2017 by Ran Kornowski
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).
- 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.
- Kick off activities,
- Clinical trial documentation,
- Regulatory submissions,
- Project management,
- eCRF management,
- CEC activities,
- Core Laboratory
- SAE reporting activities,
- Statistical activities,
- Final clinical report.
France, Germany, Israel, Italy.
23 centers managed by CERC.