NCT03454360

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

Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 107 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	ACURATE neo™ Aortic Bioprosthesis	TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.

Timeline

• Start date: 2018-02-06
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2018-03-05
• Last updated: 2020-12-11

Locations

10 sites across 1 country: Germany