ACURATE neo2™ Post Market Clinical Follow up Study

Study Overview
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Brief Summary
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The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

Detailed Description
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ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study. A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled. Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year. ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form

Official Title
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ACURATE neo2™ Post Market Clinical Follow up Study

Conditions
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Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation/Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU. Exclusion Criteria: EC1. Subject has a previous bioprosthesis in the aortic position. EC2. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V). EC3. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm. EC4. Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.

Ages Eligible for Study
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Minimum Age: 18 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: Transcatheter Aortic Valve Implantation/Replacement|The device is placed in patients heart at the level of aortic valve through a transfemoral access from femoral groin as indicated in device IFU|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint: | All-cause mortality after the index implant procedure | 30 days | 
| Primary Imaging Endpoint: | Hypoattenuated leaflet thickening (HALT) as measured by 4D CT | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints adjudicated by an independent Clinical Events Committee | All-cause mortality (cardiovascular and non-cardiovascular) Stroke (disabling and non-disabling) Bleeding (life-threatening [or disabling] and major) Vascular complications (major) Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV) | all 5 years | 
| Additional Safety Endpoints | Myocardial infarction (periprocedural [≤72 hours post index procedure] and spontaneous [>72 hours post index procedure]) Acute kidney injury (≤7 days post index procedure) based on the AKIN System Stage 3 (including renal replacement therapy) and Stage 2 Repeat procedure for valve-related dysfunction (surgical or interventional therapy) New permanent pacemaker implantation resulting from new or worsened conduction disturbances New onset of atrial fibrillation or atrial flutter Coronary obstruction (≤3 days post index procedure) Ventricular septal perforation (≤3 days post index procedure) Annular rupture (≤3 days post index procedure) Cardiac tamponade (≤3 days post index procedure) Valve migration Valve embolization Ectopic valve deployment Transcatheter aortic valve (TAV)-in-TAV deployment Prosthetic aortic valve thrombosis Prosthetic aortic valve endocarditis | all 5 years | 
| Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE) | Effective orifice area (EOA), Mean and Peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation/paravalvular leak (PVL). Center-reported TTE measures will also be collected annually at 2 through 5 years per local standard of care for TAVI. | Discharge, 30 days, annually from year 1 to 5 | 
| EuroQoL Quality of Life questionnaire (EQ-5D-5L) | Health status as evaluated by the EQ-5D-5L Quality Of Life questionnaire | Baseline, 30-day, 1-year | 
| New York Heart Association (NYHA) functional classification | Classification of heart failure symptoms as evaluated by NYHA classification | Baseline, Discharge, 30 days, annually from year 1 to 5 | 
| Assessments using 4D CT-scan | Assessment of leaflet mobility Assessment of hypoattenuated leaflet thickening (HALT) Assessment of leaflet thrombosis | 30 days 1 year |