Outcomes Following Pulmonary Valve Replacement in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-11-30

Brief Summary

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One of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation.

Multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. However, the optimal prosthetic valve for use in the pulmonary position has not been defined. There are essentially three alternatives available: the stented bioprosthetic valve, stentless bioprosthetic "tube" grafts used to replace the entire right ventricular outflow tract and mechanical valves.

All three of these valve options have been used in adults with congenital heart disease at Emory Healthcare and at Children's Healthcare of Atlanta at Egleston.

The goal of this study is to evaluate and compare the indications and short and mid-term outcomes for these alternative therapies.

Detailed Description

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Conditions

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Heart Disease, Congenital Pulmonary Valve Replacement

Keywords

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Congenital Heart Disease Pulmonary Valve Replacement

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Brian Kogon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul M Kirshbom, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Medical Center

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Emory Healthcare System

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0668-2005

Identifier Type: -

Identifier Source: org_study_id