An observational study in Heart Disease, Congenital and Pulmonary Valve Replacement, sponsored by Emory University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-26.
Sponsored by Emory University · Observational
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 300 is close to the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Adult patients who have received a pulmonary valve replacement for congenital heart disease at Children's Healthcare of Atlanta at Egleston or are in the Emory Healthcare System between 1976 and 2004.
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Exclusion Criteria:
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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Emory University