ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.

Detailed Description
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A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie 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 safety and performance of the implantation and safety at 30-D follow-up.

Official Title
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ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis

Conditions
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Aortic Symptomatic Stenosis

Intervention / Treatment
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* Device: ACURATE TA™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 75 years of age Additive EuroSCORE > 9 Severe AS assessed by echocardiography and documented by a 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 (TEE) 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 attack (TIA) or stroke in the last 3 months Untreated clinically significant coronary artery disease (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 (LVEF) < 30% by echocardiography Calcified pericardium Septal hypertrophy unacceptable for transapical procedure 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) Severe COPD requiring home oxygen History of bleeding diathesis or coagulopathy Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3) Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis Neurological disease severely affecting ambulation or daily functioning, including dementia Another surgical or percutaneous procedure scheduled at the same time 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACURATE TA™<br>Patient 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 |
| --- | --- | --- |
| Freedom from all-cause mortality at 30 day Follow Up | The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery. | 30-Day Follow-up | 
| Freedom from all-cause mortality at 12 months Follow Up | The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery. | 12 months Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as; | 2.1 Structural valve deterioration 2.2 Non-structural dysfunction of the implanted study device 2.3 Valve thrombosis, embolism, bleeding event 2.4 Operated valve endocarditis 2.5 Re-intervention on the implanted device 2.6 Valve-related mortality 2.7 Need for new permanent pacemaker or defibrillator within 14 days | 30-Days and at 12 Months Follow-up | 
| Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke. | Defined as cardiovascular death, myocardial infarction and stroke | 30-Day and 12-Month | 
| Functional Improvement from baseline | per NYHA functional classification | 30-Days and 12-Month Follow-up | 
| Procedural success | defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography as assessed at a Core Lab and without intraprocedural mortality. | 24 hours Post-Procedure | 
| Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. | Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. The following datapoints will be analyzed: 6.1 Effective orifice area and index (EOA/EOAI) 6.2 Transvalvular Gradients (Peak and mean) 6.3 Paravalvular and intravalvular (Central) leaks 6.4 Aortic Insufficiency 6.5 LV function and hemodynamics 6.6 Valve function and morphology | 30-Day and 12-Month Follow-up | 

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