ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

Study Overview
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Brief Summary
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First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts

Detailed Description
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A prospective, multicenter, CE-approval cohort analysis with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.

Official Title
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ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

Conditions
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Symptomatic Aortic Stenosis

Intervention / Treatment
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* Device: ACURATE TF™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 75 years of age and older Logistic EuroSCORE ≥ 20% Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area of < 1.0 cm2 New York Heart Association (NYHA) Functional Class > II Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE) Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis Patient willing to participate in the study and provide signed informed consent Exclusion Criteria: Unicuspid or bicuspid aortic valve Extreme eccentricity of calcification Severe mitral regurgitation ( >2+) Pre-existing prosthetic heart valve in any position and / or prosthetic ring Aortic or peripheral anatomy NOT appropriate for transfemoral implant Thoracic (TAA) or abdominal (AAA) aortic aneurysm Presence of endovascular stent graft for treatment of TAA or AAA TEE is contraindicated Left Ventricular Ejection Fraction (LVEF) < 30% by echocardiography (ECHO) ECHO evidence of intracardiac mass, thrombus, or vegetation Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure Previous Transien Ischemic Attack (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 History of bleeding diathesis or coagulopathy or refusal of blood transfusions Systolic pressure <80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP) Primary hypertrophic obstructive cardiomyopathy (HOCM) Active infection, endocarditis or pyrexia Hepatic failure Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis Refusal of surgery Severe Chronic Obstructive Pulmonary Disease (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 Known hypersensitivity/contraindication to 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: Symetis ACURATE TF™<br>Patient implanted with ACURATE TF™Bioprosthesis. | Device: ACURATE TF™<br>* ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .<br>* Other names: ACURATE TF™Transfemoral 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 | Rate of all-cause mortality | 30-Day Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System. | Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke. | 30-Days and 12 Months Follow-up | 
| Change in NYHA class over time | Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up. | 30-Day and 12-Month | 
| Procedural success during device implantation | Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality. | intraoperative | 
| Device success | Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography. The following data points will be analyzed for adequate functioning of the study device: Effective orifice area and index (EOA) Peak jet velocity Transvalvular aortic gradient (mean) Paravalvular and intravalvular (central) leak Aortic Insufficiency 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