Congenital Heart DiseaseNCT00446108
Retrospective Pulmonary Valve Replacement Imaging
An observational study of Congenital Heart Disease, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Proposal for Retrospective Review of Imaging Pre- and Post - Pulmonary Valve Replacement
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Keywords
- Pulmonary Stenosis, Right Ventricular Dilation, Right Heart Failure, Imaging, Tetralogy of Fallot
- Medical subject headings
- Heart Defects, Congenital, Pulmonary Valve Stenosis, Heart Failure, Tetralogy of Fallot
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January 1, 1994 and December 31, 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kogon, Emory University
- Investigators
- Brian E Kogon, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446108
- Sponsor's protocol ID
- IRB00002765
- Status last verified
- Nov 2013
- First submitted
- 9 Mar 2007
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Retrospective Review of Imaging Pre- and Post - Pulmonary Valve Replacement
- ClinicalTrials.gov ID
- NCT00446108
- Acronym / sponsor ID
- IRB00002765
- Conditions
- Congenital Heart Disease
- Keywords
- Pulmonary Stenosis, Right Ventricular Dilation, Right Heart Failure, Imaging, Tetralogy of Fallot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
Related trials for Congenital Heart Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian E Kogon, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.