Retrospective Pulmonary Valve Replacement Imaging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Kogon, Emory University
ClinicalTrials.gov Identifier:
NCT00446108
First received: March 9, 2007
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement. The primary interest of the study is to analyze the routine pre- and post-operative imaging studies.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Proposal for Retrospective Review of Imaging Pre- and Post - Pulmonary Valve Replacement

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The first primary aim of the study would be to identify the risk factors for early development of right heart dilation and failure following Tetralogy of fallot repair. [ Time Frame: January 1, 1994 and December 31, 2009 ] [ Designated as safety issue: No ]

    This is a retrospective chart review. The first primary aim of the study would be to identify the risk factors for early development of right heart dilation and failure following Tetralogy of fallot repair.

    The goals would be the following:

    • Determine the risk factors for early pulmonary valve replacement
    • Determine whether there is a positive correlation among the different echocardiographic and MRI parameters
    • Determine whether the parameters improve following pulmonary valve replacement
    • Determine the effects of pregnancy on the right heart
    • Determine the performance of a mechanical valve in the pulmonary position
    • Determine whether the late referral for pulmonary valve replacement worsens patient outcomes
    • Determine whether there is a time of referral beyond which surgery fails to improve patient outcome


Enrollment: 153
Study Start Date: February 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Congenital heart defects having a component of pulmonary stenosis (narrowing) are often palliated in childhood by disrupting the pulmonary valve. This arrangement can provide an excellent quality of life as these children grow and enter young adulthood. Unfortunately, the pulmonary insufficiency that is created by disrupting the pulmonary valve results in volume overload of the right heart. This may eventually lead to right ventricular dilation and irreversible right heart failure. In addition, volume load of the right heart may affect the inter-ventricular septum and left heart function as well. Placement of a competent pulmonary valve at a subsequent operation, hopefully at a time without the replacement valve size constraints present at the initial operation, is a means to eliminate the volume overload and prevent these further sequelae.

Unfortunately, the optimal timing for subsequent pulmonary valve replacement is controversial. One of the currently used indications for valve replacement includes a right ventricular to left ventricular volume ratio greater than two. However, determining the boundaries of the right ventricle by echocardiography and magnetic resonance imaging is difficult in the absence of a pulmonary valve. The boundaries are determined by an arbitrary estimation of where the pulmonary valve should be. Other potential indicators for pulmonary valve replacement may be right ventricular area and right ventricular strain, determined by echocardiography. These measurements are not affected by the absence of the pulmonary valve. They may provide better markers for impending right ventricular failure and a simpler means to follow serial improvement following valve replacement.

While the emphasis after pulmonary valve disruption typically lies on the right ventricle, there is evidence that the left ventricle may become impaired as well. Volume load on the right ventricle causes bowing of the inter-ventricular septum and affects left ventricular function. Echocardiographic imaging of the left ventricle may also be important to follow serial improvement of the left heart following pulmonary valve replacement.

All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University Hospital between January 1, 1994 and December 31, 2006. We will review approximately 125 patients' charts for patients between the ages of 1 and 65 years of age who have required pulmonary valve replacement.

  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement. The primary interest of the study is to analyze the routine pre- and post-operative imaging studies. All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University Hospital between January 1, 1994 and May 1, 2008. We will review approximately 200 patients' charts for patients between the ages of 1 and 65 years of age who have required pulmonary valve replacement.

Criteria

Inclusion Criteria:

  • history of Tetralogy of Fallot or Pulmonary Stenosis
  • Pulmonary Valve Replacement
  • Surgery at Children's Healthcare of Atlanta or Emory University Hospital between 1.1.94 and 12.31.06
  • between 1 and 65 years of age

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: NCT00446108

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Brian E Kogon, MD Emory University
  More Information

No publications provided

Responsible Party: Brian Kogon, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00446108     History of Changes
Other Study ID Numbers: IRB00002765
Study First Received: March 9, 2007
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Pulmonary Stenosis
Right Ventricular Dilation
Right Heart Failure
Imaging
Tetralogy of Fallot

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 20, 2014