NCT02306226

Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry

Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device

Detailed description

The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System. The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device. The secondary objective is to evaluate adverse events and device performance of the newly marketed device.

Conditions

• Aortic Stenosis

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-05-01
• Completion: 2017-04-01
• First posted: 2014-12-03
• Last updated: 2018-03-19