PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry

Study Overview
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Brief Summary
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The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.

Detailed Description
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The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU). Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments. The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.

Official Title
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Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL 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: Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons). Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory. The treating physician should ensure the subject will return for all required post procedure follow-up visits. Exclusion Criteria: 1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.

Ages Eligible for Study
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Minimum Age: 75 Years

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. Transfemoral access.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total aortic regurgitation over time. | total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up | post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all-cause mortality | Incidence of all-cause mortality at 30 days post index procedure | 30 days post-index procedure | 
| Clinical events as defined per VARC-2 consensus document (VARC-2) | Clinical events as defined per VARC-2 consensus document | Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure | 
| Number of patients with procedural success according to VARC II criteria | Procedural success is defined as Absence of intra-procedure mortality and 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) surgical aortic valve replacement 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. | at index- Procedure | 
| Number of patients with device success | Device success is 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: No prosthesis-patient mismatch (EAOi >0.85 cm2/m2) AND, Mean aortic valve gradient <20mmHg or peak velocity < 3 m/s AND, No moderate or severe prosthetic valve regurgitation. In evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable. | 7-days post-index procedure or discharge (whichever occurs first) | 
| Number of patients with adverse events assessed by VARC-2 Composite Safety | VARC-2 Composite Safety at 30 days defined as: All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury - Stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI) | 30 days post-index procedure | 
| Functional improvement | Functional improvement from baseline as per NYHA Functional Classification | 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure | 
| Hemodynamic function improvement from baseline | Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient | 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure | 
| Valve related dysfunction | Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript) | 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure | 

 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 Implant, Transfemoral access, Aortic valve regurgitation