ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis

Study Overview
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Brief Summary
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Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device

Detailed Description
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This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery Secondary objective is to evaluate adverse events and study device performance.

Official Title
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ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: ACURATE neo™ and ACURATE TA™ LP


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 > 40mmHg or o Peak jet velocity > 4.0m/sor Aortic valve area of < 1.0cm2 High risk candidate for conventional AVR defined as: STS score ≥ 10 or Multidisciplinary 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 Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE Patient willing to participate in the study and provides signed informed consent Exclusion Criteria: Congenital unicuspid or bicuspid aortic valve Extreme eccentricity of calcification Severe mitral regurgitation (> Grade 2) Pre-existing prosthetic heart valve in any position and / or prosthetic ring LV apex is not accessible via transapical access due to severe chest deformity Previous surgery of the LV using a patch, such as the Dor procedure Presence of apical LV thrombus Calcified pericardium Septal hypertrophy unacceptable for transapical procedure Transesophageal echocardiogram (TEE) is contraindicated ECHO evidence of intracardiac mass, thrombus, or vegetation LVEF < 30% by ECHO Emergency procedure pre-implant including CAD requiring revascularization 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 gastrointestinal (GI) bleeding within 3 months prior to implant procedure Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit History of bleeding diathesis or coagulopathy or refusal of blood transfusions Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP Primary hypertrophic obstructive cardiomyopathy (HOCM) Active infection, endocarditis or pyrexia 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, daily functioning, or dementia Life expectancy < 12 months due to non-cardiac co-morbid conditions Contraindication to study medication, contrast media, or allergy to nitinol Currently participating in an investigational drug or another device study

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Medical device trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACURATE neo™ and ACURATE TA™ LP<br>Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System | Device: ACURATE neo™ and ACURATE TA™ LP<br>* ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | incidence of all cause mortality at 30 days | 30 days | 
| Mean aortic gradient after device implantation | mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up | 7 days or Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of clinical endpoints VARC II | rate of clinical endpoints VARC II at 30 days and 12 months | 30 days and month 12 | 
| procedural success | procedural success defined as ACURATE neo™ at intended location | procedure | 
| device success assessed according to composite VARC 2 criteria | Device success defined as: ACURATE neo™ implanted in intended location No impingement of the mitral valve Normal coronary blood flow Insufficiency < Grade 3 Mean aortic gradient < 20mmHg EOA ≥ 1.0 cm2 No further re-intervention performed on the ACURATE neo™ implant | 7 days, 30 days, 12 months | 
| functional improvement from Baseline as per NYHA Functional Classification | functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up | 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, Aortic Stenosis, Transcatether Aortic Valve Implantation