ACURATE TA™ Valve Implantation Registry: SAVI 2

Launched by SYMETIS SA · Jan 21, 2016

Keywords

ClinConnect Summary

The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™.

The ACURATE TA™ is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open surgery is considered to be associated with high surgical risk.

The primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-Day Follow-up.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient has severe aortic stenosis
• • Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
• • Patient willing to participate in the study and provides signed EC-approved informed consent
• • The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
• Exclusion Criteria:
• • Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.