NCT02909556

ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.

Detailed description

Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery. The secondary objective is to evaluate adverse events and study device performance.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve replacement	Transcatheter aortic valve replacement via transfemoral access

Timeline

• Start date: 2016-12-16
• Primary completion: 2018-01-24
• Completion: 2023-01-13
• First posted: 2016-09-21
• Last updated: 2023-02-16

Locations

9 sites across 3 countries: Denmark, Germany, Switzerland