Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Study Overview
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Brief Summary
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The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study. Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.

Official Title
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Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Medtronic CoreValve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm² (<0.6cm2/m2) as determined by echocardiographic measure, ≥ 75 years, or Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or One or two (but not more than 2) of the following complicating factors: Cirrhosis of the liver (Child class A or B), Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) < 1 liter, Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery), Pulmonary hypertension > 60 mmHg and high risk of cardiac surgery other than valve replacement, Porcelain aorta Recurrent pulmonary embolus, Right ventricular insufficiency, Thoracic burning sequelae contraindicating open chest surgery, History of mediastinum radiotherapy, Severe connective tissue disease resulting in a contraindication to surgery, Cachexia (BMI ≤ 18 kg/m²), Aortic valve annulus diameter is ≥ 20 mm and ≤ 27 mm as determined by echocardiographic measure, Ascending aorta diameter £ 45 mm at the sino-tubular junction, and Signed Informed Consent. Exclusion Criteria: Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated, Any sepsis, including active endocarditis, Recent myocardial infarction (< 30 days), Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure, Any left ventricular or atrial thrombus diagnosed by echocardiography, Uncontrolled atrial fibrillation (heart rate greater than 100 bpm), Mitral or tricuspid valvular insufficiency ( > grade II), Previous aortic valve replacement (mechanical valve OR stented bioprosthetic valve), Any condition considered as contraindication for extracorporeal assistance, Evolutive or recent CVA (cerebro vascular accident), Poly arterial patients with either: Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or Symptomatic carotid or vertebral arteries narrowing (> 70%) disease, or Abdominal or thoracic aortic aneurysm, Bleeding diathesis or coagulopathy, or patient who will refuse blood transfusion, Evolutive disease with life expectancy less than one year, Creatinine clearance < 20 ml/min, Pregnancy, and Enrolled in another investigational 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: CoreValve<br> | Device: Medtronic CoreValve System<br>* Transcatheter Aortic Valve<br>* Other names: Medtronic CoreValve Percutaneous Aortic Valve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Major Adverse Event (MAE) Free Rate | Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury. | 30 (+7) days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Technical Device Success | Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the Device Functionality Assessment was achieved and who were adjudicated as having no device failure or malfunction. The four measures of the ''Device Functionality Assessment'' were: Load the valve delivery system using the loading system Access the aortic valve with the delivery catheter Deploy the valve accurately across the native aortic valve Remove the intact delivery system | Was assessed during the procedure and completed once the procedure was conlcluded |