VIVA

VIVA

Presentation during the EuroPCR 2017 by Ran Kornowski

Brief summary:

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 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:

  • Kick off activities,
  • Clinical trial documentation,
  • Regulatory submissions,
  • Project management,
  • eCRF management,
  • Monitoring,
  • CEC activities,
  • Core Laboratory
  • SAE reporting activities,
  • Statistical activities,
  • Final clinical report.

Countries:

France, Germany, Israel, Italy.

Center number:

23 centers managed by CERC.

Follow us