NCT02986737

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device

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™ and ACURATE TA™ LP	ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP 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: 2014-12-08
• Primary completion: 2015-03-03
• Completion: 2019-10-01
• First posted: 2016-12-08
• Last updated: 2020-04-09

Locations

2 sites across 1 country: Germany