Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection

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ClinicalTrials.gov Identifier: NCT00486070

Recruitment Status : Terminated (conclusions drawn, manuscript written)

First Posted : June 13, 2007

Last Update Posted : March 16, 2012

Sponsor:

Information provided by:

Children's Healthcare of Atlanta

Study Description

Brief Summary:

This is a retrospective review of charts and echocardiograms of our patients with Total Anomalous Pulmonary Venous Connection (TAPVC). The Children's Surgical and non-invasive Echo databases will be used to determine all TAPVC patients. Children's Healthcare of Atlanta and Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40 patients.

We hypothesize that the presence of descending aortic flow reversal correlates with a higher morbidity and mortality in TAPVC.

Condition or disease
Congenital Disorders

Detailed Description:

Total anomalous pulmonary venous connection (TAPVC) is a congenital cardiac anomaly in which the pulmonary veins fail to connect to the usual anatomic location, the left atrium. This may lead to critical cardio-pulmonary failure and extreme cyanosis. This condition usually requires urgent surgical repair. In many cases, the pulmonary veins may be obstructed leading to severe pulmonary hypertension and low cardiac output which may be acutely life-threatening. In these cases, emergent surgical repair is undertaken in the newborn period. Patients with TAPVC may have poor prognosis which may be difficult to predict.

We have made the unusual and previously unreported observation by echocardiography of flow reversal in the upper descending aorta, indicating extremely reduced left ventricular output in patients with TAPVC, some of whom have had a poor outcome. This has led to the hypothesis that descending aortic flow reversal portends a poor prognosis in TAPVC.

The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal. We, also, would evaluate the presence of other associated cardiac anomalies.

The second step of the study would be to review the clinical charts of the above patients to evaluate for serious co-morbidities and mortality. Outcome measures would include mortality, chronic lung disease, continued oxygen requirement, recurrent respiratory infections, listing for transplantation, cardiopulmonary arrest or requirement for ECMO.

Study Design

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Study Type :	Observational
Enrollment :	40 participants
Time Perspective:	Retrospective
Official Title:	Proposal for Retrospective Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection
Study Start Date :	December 2006
Actual Study Completion Date :	September 2007

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Pulmonary Venous Return Anomaly

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

TAPVC patients

Criteria

Inclusion Criteria:

Children's Healthcare of Atlanta and Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40 patients.

The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal.

Exclusion Criteria:

those who do not fall under the Inclusion Criteria

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486070

Locations

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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Children's Healthcare of Atlanta

Investigators

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Principal Investigator:	Derek A Fyfe, MD, PhD	Sibley Heart Center Cardiology at Children's Healthcare of Atlanta

More Information

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Responsible Party:	Director Research, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier:	NCT00486070
Other Study ID Numbers:	06-197
First Posted:	June 13, 2007 Key Record Dates
Last Update Posted:	March 16, 2012
Last Verified:	January 2008

Keywords provided by Children's Healthcare of Atlanta:


cardiac anomaly pulmonary veins cyanosis flow reversal TAPAVC

Additional relevant MeSH terms:

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Scimitar Syndrome Lung Diseases Respiratory Tract Diseases Respiratory System Abnormalities Vascular Malformations	Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Congenital Abnormalities

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