Comparison Between Three Types of Stented Pericardial Aortic Valves

Study Overview
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Brief Summary
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This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

Detailed Description
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According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers. Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans. Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

Official Title
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Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves

Conditions
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Aortic Valve Replacement

Intervention / Treatment
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* Procedure: Aortic valve replacement by bioprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 85 years who need aortic valve replacement (no endocarditis) With Bioprosthesis, with or without myocardial revascularization, with or without tricuspid valve repair surgery Exclusion Criteria: no endocarditis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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

Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pericardial aortic valves<br>Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences) | Procedure: Aortic valve replacement by bioprosthesis<br>* Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of postoperative trans-valvular mean gradient by echocardiography |  | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size |  | at six months | 
| Comparison between the aortic annulus measurement and the implanted bioprosthesis size |  | at six months | 
| Surgical outcome at hospital |  | at 6 months. | 
| Postoperative trans-valvular mean gradient by echocardiography |  | at six months. | 
| Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces |  | at six months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioprosthesis,, aortic valve replacement, Magna Ease, Mitroflow, Trifecta