Children and Adolescents Receiving Mechanical and Prosthetic Valves

Stopped early

Conditions studied: Congenital Disorders

In brief

The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial endocarditis (SBE), structural failure or deterioration , valve thrombosis, explantation and reimplantation with reason, death and death cause, and cerebrovascular accidents either permanent or transient in nature. Secondary to this is the presumption that mechanical valves have a superior "life expectancy " to bio-prosthetic valves. We plan to look at the time of freedom from re-implantation from different types of valves, factoring in patient age, size ,defect and risk factors. The information learned from this study may benefit future patients who undergo the Ross procedure by increasing our knowledge of safer and/or more effective techniques.

Key facts

Study ID

NCT00268008

Run by

Children's Healthcare of Atlanta

People needed

300

Starts

1976-01-01

Last updated by the study team

2007-05-07

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Valve replacement in the mitral or aortic position
• replacement at Children's Healthcare of Atlanta
• replacement between 1976 and 2002
• implants may be mechanical, bio-prosthetic or homograft

You may not qualify if…

• those who do not meet inclusion criteria

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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