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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: ACURATE neo™ Aortic Bioprosthesis


Participation Criteria
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Eligibility Criteria
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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;
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ACURATE neo™ Aortic Bioprosthesis|TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | the rate of all-cause mortality as measured at 30-days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Clinical events as defined per VARC 2 consensus document at procedure: All cause mortality; Stroke; Myocardial Infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications | Procedure to Discharge, 30 days and 12-months | 
| Procedural Success | Defined as absence of intra-procedure mortality (procedure to 24H) AND absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment) or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication. The procedure can be considered as success despite the presence of residual aortic regurgitation, which may be due to the anatomic configuration of the annulus or a calcific valvular annulus. | Procedure to 24-hours | 
| Device Success | Defined as; Absence of intra-procedure mortality (procedure to 24H) AND, Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve assessed prior to discharge per local standard of care and defined as: No prosthesis-patient mismatch (EAOi >0.85 cm2/m2 or EAOi >0.7 cm2/m2 for BMI ≥30 kg/m2) ) AND, Mean aortic valve gradient <20mmHg or peak velocity < 3 m/s AND, No moderate or severe prosthetic valve regurgitation. For echo parameters for the performance assessment, a pre-discharge echo examination should be performed as per local standard of care. If echo parameter pre-discharge is missing, any echo parameter within 45 days post-procedure may be used. | Post-procedure to Discharge. | 
| VARC 2 Composite Safety | Defined as: All-cause mortality All stroke Life-threatening bleeding Acute Kidney Injury- Stage 2 or 3 Coronary Artery Obstruction requiring intervention Major Vascular Complications Valve-related dysfunction requiring repeat procedure | 30-days | 
| Functional improvement as per NYHA Functional Classification | Change on NYHA Class between baseline and different follow-up | from baseline to, discharge, 30-days and 12-months follow-up. | 
| Improvement of EOA and mean Trans-prosthetic gradient | If the echo parameter pre-discharge is missing to assess the intended performance, any echo parameter data within 45-days post procedure may be used for the missing values; | from baseline to discharge, 30- days and 12 months follow-up | 
| Total Aortic Regurgitation | Change on Aortic Regurgitation over time at follow-up | post-procedure, prior to discharge, at 30-days and 12-months follow-up; | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve, Transapical Access