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Biomodel in Tetralogy of Fallot

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00155428
First Posted: September 12, 2005
Last Update Posted: December 20, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Condition Intervention
Tetralogy of Fallot Procedure: rapid prototyping Procedure: computed tomography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application of Biocardiac Model in Total Correction of Tetralogy of Fallot

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • diagnostic accuracy

Secondary Outcome Measures:
  • sensitivity
  • specificity

Estimated Enrollment: 50
Study Start Date: May 2005
Estimated Study Completion Date: December 2008
Detailed Description:
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Tetralogy of Fallot

  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): NCT00155428


Locations
Taiwan
Dept. Medical Imaging, NTUH Recruiting
Taipei, Taiwan, 100
Contact: Shyh-Jye Chen, MD, PhD    +886-23565586    james@ntumc.org   
Principal Investigator: Shyh-Jye Chen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shyh-Jye Chen, MD, PhD Dept. Medical Imaging, NTUH
  More Information

ClinicalTrials.gov Identifier: NCT00155428     History of Changes
Other Study ID Numbers: 9461700518
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: December 20, 2005
Last Verified: May 2005

Keywords provided by National Taiwan University Hospital:
biomodel
rapid prototyping
computed tomograpgy

Additional relevant MeSH terms:
Tetralogy of Fallot
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities