Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
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|ClinicalTrials.gov Identifier: NCT00630916|
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : September 20, 2011
Last Update Posted : September 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Heart Valve Diseases||Device: Mitroflow Aortic Heart Valve||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||756 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2007|
|No Intervention: A||
Device: Mitroflow Aortic Heart Valve
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
Other Name: Mitroflow
- Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair [ Time Frame: Late postoperative ]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 ]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 ]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 ]Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630916
Show 26 Study Locations
|Study Director:||Mary Onxley||Sorin Group USA, Inc.|