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CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

2014-07-24 14:06:46 | BioPortfolio

Summary

The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Description

The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Pulmonary Valve Stenosis

Intervention

Echocardiogram

Location

Indiana University
Indianapolis
Indiana
United States
46202

Status

Enrolling by invitation

Source

CryoLife, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:06:46-0400

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Medical and Biotech [MESH] Definitions

The pathologic narrowing of the orifice of the PULMONARY VALVE. This lesion restricts blood outflow from the RIGHT VENTRICLE to the PULMONARY ARTERY. When the trileaflet valve is fused into an imperforate membrane, the blockage is complete.

A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

Narrowing below the PULMONARY VALVE or well below it in the infundibuluar chamber where the pulmonary artery originates, usually caused by a defective VENTRICULAR SEPTUM or presence of fibrous tissues. It is characterized by restricted blood outflow from the RIGHT VENTRICLE into the PULMONARY ARTERY, exertional fatigue, DYSPNEA, and chest discomfort.

The pathologic narrowing of the orifice of the TRICUSPID VALVE. This hinders the emptying of RIGHT ATRIUM leading to elevated right atrial pressure and systemic venous congestion. Tricuspid valve stenosis is almost always due to RHEUMATIC FEVER.

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