Sponsor Name

CERIC

Grant Giver Name

Boston Scientific

Brief summary

MENA TAVI is a single arm, prospective, open label and multicenter registry. The objective is to evaluate the ACURATE NEO 2 in the Middle East population suffering from severe symptomatic aortic stenosis. The objective is to enroll 100 patients from 6 investigational sites and patients will be followed up to 30 days after procedure.

Primary endpoints

The primary endpoint is the combined endpoint at discharge of

• All cause mortality or
• Any stroke (disabling and non-disabling)

CERC Services

Regulatory submissions,

Project management,

Contract management,

Monitoring (subcontracted),

SAE reporting,

Data management/EDC,

CEC organization,

Corelab activities,

Statistical analysis 

Countries

Around 3 countries across Saudi Arabia, Egypt and Lebanon.

Number of investigational sites: 6