NCT03143686

ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)

• 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 provide safety surveillance of the device.

Detailed description

A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.

Conditions

• Symptomatic 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: 2011-11-01
• Primary completion: 2012-12-01
• Completion: 2013-11-01
• First posted: 2017-05-08
• Last updated: 2018-03-19

Locations

17 sites across 4 countries: Argentina, Germany, Italy, Switzerland