NCT02950428

ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis

ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE Neo™ TA Transapical Delivery System in Patients With Severe Aortic Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.

Detailed description

This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery Secondary objective is to evaluate adverse events and study device performance.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	ACURATE neo™TA Delivery System	ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk

Timeline

• Start date: 2015-11-18
• Primary completion: 2017-04-17
• Completion: 2021-09-03
• First posted: 2016-11-01
• Last updated: 2023-02-23

Locations

7 sites across 1 country: Germany