Sponsor Name : CERIC (investigator initiated trial)

Grant Giver: Biosensors international

Brief summary

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.

Primary endpoints

Trans-aortic mean gradient 30 days after transcatheter valve implantation procedure, measured by transthoracic echocardiography

CERC Services

• Submission to competent authorities and ethic committees
• Contract and payment management for hospitals
• EDC setup and data management, monthly report
• SIV and monitoring
• Corelab –echo analysis
• Statistical activities
• CEC meeting
• Safety activities (MedDRA coding, annual report)
• Clinical study report (final and primary endpoint)

Countries

7 countries (tentative) in Europe

Number of investigational sites:

12 centers (tentative)

Number of patients

130 females