NCT00705913

Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

A Randomized Study to Compare Sizing, Implant Techniques and Hemodynamic Performance Between the Mitroflow and the Carpentier-Edwards Magna Pericardial Tissue Valves in the Aortic Position

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Sorin Group USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.

Detailed description

Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Mitroflow Aortic Pericardial Heart Valve (CarboMedics)	Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve
DEVICE	Carpentier-Edwards Magna Tissue Valve	Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-06-27
• Last updated: 2012-01-09

Locations

12 sites across 2 countries: United States, Canada