NCT00276237

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2005

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

First QC Date

January 12, 2006

Last Update Submit

November 25, 2013

Conditions

Heart Disease, CongenitalPulmonary Valve Replacement

Keywords

Congenital Heart DiseasePulmonary Valve Replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory Healthcare System

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Paul M Kirshbom, MD

    Emory University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

July 1, 2005

Study Completion

November 1, 2005

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

US(2)