All Women study is a unique newly launching randomized controlled trial targeting female population older than 75 years old with symptomatic aortic stenosis. The objective is to demonstrate lower mean gradient by Echo 30 days after TAVI procedure with Allegra (Biosensors), versus patients treated by balloon expandable TAVI.
Sponsor
Primary endpoints
Trans-aortic mean gradient 30 days after transcatheter valve implantation procedure, measured by transthoracic echocardiography
CERC Services
- CEC meeting
- Contract and payment management for hospitals
- EDC setup and data management, monthly report
- Submission to competent authorities and ethic committees
Countries
7 countries (tentative) in Europe
Number of investigational sites
12 centers (tentative)
Number of patients
130 females
