Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve|
- Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair [ Time Frame: Late postoperative ] [ Designated as safety issue: Yes ]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.
- Mean Gradient [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Effective Orifice Area [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Aortic Valve Regurgitation [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
|Study Start Date:||November 2003|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
|No Intervention: A||
Device: Mitroflow Aortic Heart Valve
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
Other Name: Mitroflow
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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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.
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|Study Director:||Mary Onxley||Sorin Group USA, Inc.|