Retrospective Pulmonary Valve Replacement Imaging

NCT00446108 | Completed

• 1 other identifier: IRB00002765
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 2

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.

Conditions

Congenital Heart Disease

Keywords

Pulmonary Stenosis; Right Ventricular Dilation; Right Heart Failure; Imaging; Tetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  January 1, 1994 and December 31, 2009

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Pulmonary Valve Stenosis; Heart Failure; Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Brian E Kogon, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 12, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

US (2)