NCT02663375

ACURATE TA™ Valve Implantation Registry: SAVI 2

Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.

Detailed description

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	ACURATE TA™ Transapical Aortic Bioprosthesis	ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-01-01
• Completion: 2016-01-01
• First posted: 2016-01-26
• Last updated: 2018-03-19

Locations

27 sites across 4 countries: Austria, Germany, Italy, Switzerland