Trial record 1 of 1 for:    "Pulmonary venous return anomaly"
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Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection

This study has been terminated.
(conclusions drawn, manuscript written)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00486070
First received: June 12, 2007
Last updated: March 14, 2012
Last verified: January 2008
  Purpose

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
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Proposal for Retrospective Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 40
Study Start Date: December 2006
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00486070

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Derek A Fyfe, MD, PhD Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Director Research, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00486070     History of Changes
Other Study ID Numbers: 06-197
Study First Received: June 12, 2007
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
cardiac anomaly
pulmonary veins
cyanosis
flow reversal
TAPAVC

Additional relevant MeSH terms:
Scimitar Syndrome
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Lung Diseases
Respiratory System Abnormalities
Respiratory Tract Diseases
Vascular Diseases
Vascular Malformations

ClinicalTrials.gov processed this record on October 29, 2014