Children and Adolescents Receiving Mechanical and Prosthetic Valves

This study has been terminated.
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00268008
First received: December 20, 2005
Last updated: May 3, 2007
Last verified: May 2007
  Purpose

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
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Retrospective Review of Children and Adolescents Receiving Mechanical and Prosthetic Valves in the Aortic and Mitral Position 1976-2002

Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 300
Study Start Date: January 1976
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • those who do not meet inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268008

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Kirk R. Kanter, MD Emory Univ. SOM Cardiothoracic Surgery of Children's Healthcare of Atlanta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00268008     History of Changes
Other Study ID Numbers: 05-033
Study First Received: December 20, 2005
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
aortic valve replacement
mitral valve replacement
valvular stenosis
Ross procedure
Homograft valves
Bio-prosthetic valves
Mechanical valves

ClinicalTrials.gov processed this record on August 21, 2014