Nitinol Circular Blade

Study Overview
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Brief Summary
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The Nitinol Circular Blade (NCB) is indicated for use in patients with symptomatic aortic stenosis requiring aortic valve replacement, who are going to be operated by conventional sternotomy with native valve resection and replacement by a prosthetic aortic valve. The resection of the diseased leaflets will be performed by the NCB rather than conventional surgical blade.

Detailed Description
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The patient will be under general anesthesia. The sternum will be opened fully or partially. The patient will be prepared for cardiopulmonary bypass. A transversal aortotomy will be performed as usual. The aortic valve will be exposed for the resection. The NCB will be inserted under visual control from the aorta to the left ventricle. The collection chamber will be closed and the circular blade can be advanced forward to resect the diseased native aortic valve. Once the resection is completed the device will be retrieved carefully. Complementary fine cleaning of the aortic annulus can be done by the surgeon in order to prepare the annulus to receive the prosthetic valve. After implantation of the new valve classically the aortotomy will be closed. Standard weaning of cardiopulmonary bypass will be done and the operation will be safely completed. The aim of this blade is to evaluate the resection time, test the efficiency of a circular Nitinol blade during resection of the calcified native aortic leaflets. A careful examination of the resection edges, aortic annulus, mitral valve and all surrounding tissues will be done in order to validate the efficacy of this Nitinol Circular Blade.

Official Title
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Transaortic Native Valve Resection Using a Novel Nitinol Blade Device Rather Than a Classical Surgical Blade (Nitinol Circular Blade)

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Aortic valve replacement using a nitinol blade
* Procedure: aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient >40 mmHg; max velocity >4 m/sec; aortic valve area <=0.8 cm2. Symptoms related to aortic valve disease, and NYHA Functional Class II or greater Subject is indicated for aortic valve implantation with a biological prosthesis (tissue valve) Age >= 65 years Echocardiographically determined aortic annulus diameter >=24 mm and <=30 mm in a long-axis view Subject understands the implications of participating in the study and provides informed consent Exclusion Criteria: Congenital unicuspid aortic valve Severe eccentricity of calcification, defined as calcium deposits larger than 6 mm in diameter Echocardiographic evidence of intracardiac mass, thrombus or vegetation Left ventricular ejection fraction <25% as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available Hypertrophic obstructive cardiomyopathy Subjects with life expectancy less than 12 months due to an underlying non-cardiac co-morbid disease Known hypersensitivity or contraindication that cannot be adequately controlled with pre-medication to any study medication or material, such as contrast medium or Nitinol Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy Renal insufficiency assessed by creatinine >2.5 mg/dl and/or end stage renal disease requiring chronic dialysis Poor lung function that in the investigator's opinion is prohibitive for thoracotomy Active peptic ulcer or GI bleeding within 3 months from the planned index procedure Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance Peripheral vascular disease, including abdominal and thoracic aortic disease, that could pose a problem for eventual transarterial mechanical support (e.g. intraaortic balloon pump) History of myocardial infarction in the last 6 weeks History of TIA or CVA in the last 6 months Subject refuses to have a blood transfusion Subject is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial

Ages Eligible for Study
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Minimum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resection of the aortic valve leaflets with device<br>Patients in which the aortic valve has been resected using the nitinol blade | Device: Aortic valve replacement using a nitinol blade<br>* A circular nitinol blade will be inserted by to cut the aortic valve leaflets during conventional aortic valve replacement procedure<br>|
| Other: Resection of the aortic valve leaflets in standard fashion<br>Patients in which the aortic valve has been resected using a conventional blade or scissor | Procedure: aortic valve replacement<br>* Aortic valve replacement in a standard fashion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success of the resection | Resection of the aortic valve leaflets by the circular nitinol blade | Hospital discharge : in average 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication due to the use of the device | Any complication related to the use of the nitinol blade | 1 year |