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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

2014-08-27 03:32:24 | BioPortfolio

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.

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 Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Heart Valve Diseases

Intervention

Mitroflow Aortic Heart Valve

Location

Banner Good Samaritan
Phoenix
Arizona
United States
85006

Status

Completed

Source

Sorin Group USA, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:24-0400

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PubMed Articles [13327 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

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The downward displacement of the cuspal or pointed end of the trileaflet AORTIC VALVE causing misalignment of the cusps. Severe valve distortion can cause leakage and allow the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to aortic regurgitation.

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