Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Symetis SA
- Enrollment
- 107
- Locations
- 10
- Primary Endpoint
- All cause mortality
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
All cause mortality
Time Frame: 30 days
the rate of all-cause mortality as measured at 30-days
Secondary Outcomes
- Safety and performance 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.(Procedure to Discharge, 30 days and 12-months)
- Procedural Success(Procedure to 24-hours)
- Device Success(Post-procedure to Discharge.)
- VARC 2 Composite Safety(30-days)
- Functional improvement as per NYHA Functional Classification(from baseline to, discharge, 30-days and 12-months follow-up.)
- Improvement of EOA and mean Trans-prosthetic gradient(from baseline to discharge, 30- days and 12 months follow-up)
- Total Aortic Regurgitation(post-procedure, prior to discharge, at 30-days and 12-months follow-up;)