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Children and Adolescents Receiving Mechanical and Prosthetic Valves

NCT00268008 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2007-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Disorders

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    lead OTHER

Principal Investigators

  • Kirk R. Kanter, MD · Emory Univ. SOM Cardiothoracic Surgery of Children's Healthcare of Atlanta

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1976-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00268008 on ClinicalTrials.gov