Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 7:10 AM
Study NCT ID:
NCT05847751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2023-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
Sponsor:
Ceric Sàrl
Organization:
Study Overview
Official Title:
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BSC07
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: