This is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results. This pre-CE marked trial is conducted in two countries (France and the UK) with 5 Investigation sites participate to the trial.
The recruitment was finalized in Sept 2023, a total of 26 patients were enrolled in the trial.
The primary study endpoints, which were reached in October 2023, were presented by Dr. Bernard Chevalier in the Late-Breaking Trials session at London Valve 2023.
Sponsor
Study objectives
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
Primary endpoints
Rate of all-cause mortality and stroke at 30 days post implantation
CERC Services
- CEC and DSMB activities
- Project management
- Regulatory submissions
- Site and Monitoring Management
- Statistical Analysis and Clinical report
Countries
FRANCE AND THE UK
Number of investigational sites
05 sites
