NCT05847751

The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Ceric Sàrl · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.

Detailed description

The MENA-TAVI study is an investigator-initiated, prospective, single-arm observational trial. Patients referred for or presenting with severe aortic stenosis requiring an intervention constitute the source population. The Heart Team consisting of interventional cardiologists and cardiovascular surgeons will evaluate the patients by integrating the available clinical data, the predicted 30-day mortality, individual factors affecting mortality such as frailty as well as the estimated life-expectancy and the patient's wishes to finally reach a consensus on the optimal treatment strategy with regards to transcatheter or surgical aortic valve replacement. Patients planned for TAVI will be screened for eligibility. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. In case of consent, they will be treated by the ACURATE neo2 aortic bioprosthesis. At discharge and at 30 days, the clinical outcomes composing the primary safety endpoint will be captured. Additional clinical, procedural and echocardiographic data will be obtained at discharge and at 30 days for assessment of secondary endpoints.

Conditions

• Severe Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Aortic valve replacement	Trans Aortic Valve Replacement (TAVI)

Timeline

• Start date: 2024-03-06
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2023-05-08
• Last updated: 2026-01-07

Locations

7 sites across 3 countries: Egypt, Lebanon, Saudi Arabia