Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)

Study Overview
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Brief Summary
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Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Detailed Description
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A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating the feasibility and performance of the implantation and the safety at 30-Day follow-up.

Official Title
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Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis

Conditions
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Aortic Stenosis Symptomatic

Intervention / Treatment
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* Device: ACURATE TA™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 75 years; Additive EuroSCORE > 9 and/or STS > 9%; Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient > 40mmHg,and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²; NYHA Functional Class > II; Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography; Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) [STJ>1.1xAAn] AND STJ<45mm by transoesophageal echocardiography; Patient understands the implications of participating in the study and provides signed informed consent Exclusion Criteria: Congenital unicuspid or bicuspid aortic valve; Severe eccentricity of calcification; Severe mitral regurgitation (> 2°); Pre-existing prosthetic heart valve in any position and /or prosthetic ring; Severe transapical access problem, non-reachable LV apex; Previous surgery of the LV using a patch, such as the Dor procedure; Presence of apical LV thrombus; Echocardiographic evidence of intracardiac mass, thrombus, or vegetation; Acute Myocardial Infarction (AMI) within 1 month prior to the procedure; PCI within 1 month prior to the procedure; Previous Transient Ischemic Accident (TIA) or stroke in the last 3 months; Untreated clinically significant CAD requiring revascularization; Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump; Severe left ventricular dysfunction with a LV Ejection Fraction (LVEF) < 25% by echocardiography; Calcified pericardium; Septal hypertrophy; Primary Hypertrophic Obstructive Cardiomyopathy (HOCM); Active infection, endocarditis or pyrexia; Active peptic ulcer or Gastrointestinal (GI) bleeding within the past 3 months; Significant hepatic involvement (Child > B); Major lung disease (FEV < 0.8 or FEV1% < 30% of normal); Pulmonary hypertension; History of bleeding diathesis or coagulopathy; Hematologic disorder (WBC<3000mm3, Hb<9g/dL, platelet count <50000 cells/ mm3); Serum creatinine level greater than 3.0 mg/dL or chronic renal failure requiring dialysis; Neurological disease severely affecting ambulation or daily functioning, including dementia; Other procedure scheduled at the same time, whether surgery or percutaneous approach; Emergency procedure; Life expectancy < 12 months due to non-cardiac co-morbid conditions; Known hypersensitivity/contraindication to any study medication, contrast media, or 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Medical Device Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACURATE TA™<br>Patients implanted with ACURATE TA™ Bioprosthesis | Device: ACURATE TA™<br>* ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement surgery.<br>* Other names: ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint | Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance endpoint | Stable ACURATE placement at intended site as assessed by angiography | Up to 24-hours post-procedure | 
| Performance endpoint | Adequate ACURATE device function as assessed by echocardiography | Up to 24-hours post-procedure | 
| Mortality | Freedom from Death at follow-up | 30 days, 60 days, 3 months, 6 months and 12 months | 
| MAVRE at follow-up | Rate of MAVRE at follow-up | discharge or 7 days, 3 months, 6 months and 12 months | 
| MACCE or Major Adverse Cardiac and Cerebrovascular Event | Rate of MACCE at follow up | 1 month, 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Symptomatic Aortic Valve Stenosis