COLIBRI

Brief summary:

The objective of this study is to evaluate the safety and performance of the Colibri Transcatheter Aortic Heart Valve System for the treatment of symptomatic severe aortic stenosis via transfemoral access in high surgical risk patients.

This is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.

Primary endpoint:

Rate of all-cause mortality and stroke at 30 days post implantation

CERC Services:

Regulatory Submissions

Project Management

Contract Management

Monitoring

SAE Reporting

Data Management/EDC

CEC/DSMB activities

Corelab activities

Statistical Analysis

Countries:

3 Countries

 Number of patient:

30

Center number:

7 centers