ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Study Overview
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Brief Summary
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Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.

Detailed Description
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Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery. The secondary objective is to evaluate adverse events and study device performance.

Official Title
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ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: Transcatheter aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 75 years of age and older Severe aortic stenosis defined as: Mean aortic gradient > 40 mmHg or Peak jet velocity > 4.0 m/s or Aortic valve area of < 1.0 cm2 High risk candidate for conventional AVR defined as: Logistic EuroSCORE 1 ≥ 20% or STS Score ≥ 8% or Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis NYHA Functional Class > II Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT Patient willing to participate in the study and provides signed informed consent Exclusion Criteria: Congenital aortic stenosis or unicuspid or bicuspid aortic valve Non-stenotic Aortic Insufficiency Severe eccentricity of calcification Severe mitral regurgitation (>2+) Presence of mitral bioprosthesis Presence of previously implanted aortic bioprosthesis Presence of prosthetic ring Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries Thoracic (TAA) or abdominal (AAA) aortic aneurysm Presence of endovascular stent graft for treatment of TAA or AAA Trans-oesophageal echocardiogram (TEE) is contraindicated Evidence of intra-cardiac mass, thrombus or vegetation Severe ventricular dysfunction with ejection fraction < 20% Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure Acute Myocardial Infarction within 1 month prior to implant procedure Previous TIA or stroke within 3 months prior to implant procedure Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit Severe coagulation conditions Refusal of blood transfusions Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP Hypertrophic cardiomyopathy with or without obstruction Active bacterial endocarditis or other active infections Hepatic failure (> Child B) Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis Refusal of surgery Severe COPD requiring home oxygen Neurological disease severely affecting ambulation or daily functioning, or dementia Life expectancy < 12 months due to non-cardiac co-morbid conditions Inability to tolerate anticoagulation therapy Contraindication to contrast media or allergy to nickel Currently participating in an investigational drug or another device study Non-valvular aortic stenosis Non-calcific acquired aortic stenosis

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACURATE neo AS<br> | Device: Transcatheter aortic valve replacement<br>* Transcatheter aortic valve replacement via transfemoral access<br>* Other names: ACURATE neo™ AS TF Transfemoral Delivery System (Commercial name: ACURATE neo2™ Transfemoral Delivery System);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality at 30 days follow-up |  | 30 days post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical events as defined per VARC guidelines | Clinical events: Mortality Stroke Myocardial infarction Bleeding complication Acute kidney injury Vascular complication Conduction disturbances and arrhythmia Other TAVI-related complications | 7 days, 30 days, 12 months post-implant | 
| Procedural success | 2. Procedural success defined as 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 aortic bioprosthesis (valve in valve); or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication | Day of implant | 
| Device success | 3. Device success defined as: Absence of intra-procedure mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (EOAi >0.85 cm2/m2 and mean aortic valve gradient <20mmHg without moderate or severe AR) | Day of implant | 
| VARC Composite Safety at 30 days |  | 30 days | 
| Clinical improvement from baseline as per NYHA Functional Classification |  | 7 days, 30 days, 12 months post-implant | 
| Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient |  | 7 days, 30 days, 12 months | 
| Total aortic regurgitation |  | 7 days, 30 days, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Replacement, TAVI, Transcatheter Aortic Valve Implant, Transfemoral access