Children and Adolescents Receiving Mechanical and Prosthetic Valves
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00268008|
Recruitment Status : Terminated
First Posted : December 22, 2005
Last Update Posted : May 7, 2007
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Enrollment :||300 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Retrospective Review of Children and Adolescents Receiving Mechanical and Prosthetic Valves in the Aortic and Mitral Position 1976-2002|
|Study Start Date :||January 1976|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268008
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kirk R. Kanter, MD||Emory Univ. SOM Cardiothoracic Surgery of Children's Healthcare of Atlanta|