NCT00630916

Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 756 (actual)
• Sponsor: Sorin Group USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	Mitroflow Aortic Heart Valve	Replacement of the native aortic valve or a previously implanted prosthetic aortic valve

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-12-01
• Completion: 2007-12-01
• First posted: 2008-03-07
• Last updated: 2011-09-22
• Results posted: 2011-09-20

Locations

26 sites across 2 countries: United States, Canada