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Biomodel in Tetralogy of Fallot

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ClinicalTrials.gov Identifier: NCT00155428
Recruitment Status : Unknown
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : December 20, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Condition or disease Intervention/treatment
Tetralogy of Fallot Procedure: rapid prototyping Procedure: computed tomography

Detailed Description:
Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : May 2005
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. diagnostic accuracy

Secondary Outcome Measures :
  1. sensitivity
  2. specificity

Eligibility Criteria

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 Posted: September 12, 2005    Key Record Dates
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