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.
ID: NCT05847751
Sponsor
Primary endpoints
The primary endpoint is the combined endpoint at discharge of:
- All cause mortality or
- Any stroke (disabling and non-disabling)
CERC Services
- Project management
- Regulatory submissions
- Contract management
- SAE Reporting
- EDC and data management
- CEC activities
- CoreLab activities
- Statistical Analysis
Countries
3: Saudi Arabia, Egypt, Lebanon
Number of investigational sites
6
Number of patients
100
