Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
|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.
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.|