ACURATE TA™ Valve Implantation Registry: SAVI 2 (TA-SAVI2)

Symetis

Status: Completed

Conditions: Aortic Stenosis

Treatments: Device: ACURATE TA™ Transapical Aortic Bioprosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT02663375

2013-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 1 patient group

ACURATE TA™ Transapical Aortic Biorposthesis

Description:

Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System

Treatment:

Device: ACURATE TA™ Transapical Aortic Bioprosthesis