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Retrospective Pulmonary Valve Replacement Imaging

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ClinicalTrials.gov Identifier: NCT00446108
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Brian Kogon, Emory University

Tracking Information
First Submitted Date March 9, 2007
First Posted Date March 12, 2007
Last Update Posted Date November 26, 2013
Study Start Date February 2007
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2013)
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 ]
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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00446108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Pulmonary Valve Replacement Imaging
Official Title Proposal for Retrospective Review of Imaging Pre- and Post - Pulmonary Valve Replacement
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Congenital Heart Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 14, 2012)
153
Original Enrollment
 (submitted: March 9, 2007)
125
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00446108
Other Study ID Numbers IRB00002765
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Brian Kogon, Emory University
Study Sponsor Emory University
Collaborators Not Provided
Investigators
Principal Investigator: Brian E Kogon, MD Emory University
PRS Account Emory University
Verification Date November 2013