NCT03003650

ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts

Detailed description

A prospective, multicenter, "CE-approval cohort" analysis with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.

Conditions

• Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	ACURATE TF™	ACURATE TF™Transfemoral 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: 2011-09-01
• Primary completion: 2013-07-01
• Completion: 2017-08-01
• First posted: 2016-12-28
• Last updated: 2018-11-27

Locations

6 sites across 3 countries: Brazil, Germany, Japan