CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System

Symetis

Status: Terminated

Conditions: Aortic Stenosis

Treatments: Device: ACURATE neo™ Aortic Bioprosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT03454360

2016-03

Details and patient eligibility

About

The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.

Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.

As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.

Full description

The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.

Enrollment: 107 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic patients with severe aortic stenosis;
• Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;

Exclusion criteria

• Patients unable or unwilling to give inform consent;