Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Study Overview
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Brief Summary
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This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Detailed Description
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Bioprosthetic heart valves offer several advantages over mechanical valves, the most important being freedom from the need for anticoagulation and a low rate of thromboembolic events. Pericardial bioprosthetic valves are known to have hemodynamic performance superior to porcine valves, and the excellent hemodynamic performance of pericardial valves is particularly relevant in patients with a small aortic root. However, long-term durability continues to be the main concern with use of pericardial valves. Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation techniques and design failure rather than the pericardial tissue.The unique desing of the Mitroflow Aortic Heart Valve may provide superior hemodynamic performance over other tissue valves.

Official Title
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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Device: Mitroflow Aortic Heart Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is male or female 18 years old or older The subject or subject's legal representative is willing to sign the informed consent A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable Exclusion Criteria: The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position The patient requires a double or triple valve replacement The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted The patient has active endocarditis The subject is or will be participating in a concomitant research study of an investigational product The subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br> | Device: Mitroflow Aortic Heart Valve<br>* Replacement of the native aortic valve or a previously implanted prosthetic aortic valve<br>* Other names: Mitroflow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring >30 days after valve implant. | Late postoperative | 
| Mean Gradient | Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size. | 12 months | 
| Effective Orifice Area | Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic Valve Regurgitation | Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve insufficiency, Aortic valve, Aortic disease, Aortic incompetence