The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, in the context of an observational investigator-initiated trial (IIT). There are no additional and/or invasive measures for the patient besides his routine clinical treatment. However, in addition to the mere observation of routine parameters needed for clinical treatment, additional data will be generated by extended analyses of the imaging and clinical data obtained during clinical routine. These will be analyzed to gain further insights regarding the optimal treatment of patients with severe aortic stenosis.
This is a single arm, multicenter, prospective, non-randomized, observational study with embedded substudies. The trial product is used according to its CE certificate and intended use.
Sponsor
Study objectives
To further evaluate the safety, efficacy, and device performance of the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system in 2000 consecutive patients with severe aortic stenosis according to VARC-3 criteria.
Primary endpoints
All-cause mortality up to 12 months follow-up
Countries
France
Number of investigational sites
2
Number of patients
1043
