ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)

Study Overview
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Brief Summary
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First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe 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, non-randomized, open trial, up to 5 Years follow-up 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.

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

Conditions
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Aortic Stenosis Symptomatic

Intervention / Treatment
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* Device: ACURATE TF™ Aortic Valve System


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 < 1.0 cm2 New York Heart Association (NYHA) Functional Class > II Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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 Trans-esophageal echocardiogram (TEE) is contraindicated Left Ventricle 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 Transient 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 Obstruction 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: ACURATE TF™ Aortic Valve System<br>ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement . | Device: ACURATE TF™ Aortic Valve System<br>* Transcatheter Aortic Valve Implantation<br>|

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-Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MACCE (major cardiac and cerebrovascular event) | Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke | 30-Days and 12-Months |