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NCT00498446 Clinical Trial

Magnetic Resonance Imaging of Atrial Septal Defects

Atrial Septal Defect Clinical Trial

Official title:
Imaging of Atrial Septal Defects by Velocity Encoded Cardiovascular Magnetic Resonance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00498446
Other study ID # 3938
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2002
Est. completion date July 2004

Study information
Verified date July 2007
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure. Depending on the size and severity of the ASD, They can be treated during a heart catheterization with a special device that can permanently seal the ASD, but knowing the exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical ways for evaluating an ASD.

Description:

Background: Atrial septal defect (ASD) flow can be measured indirectly by velocity-encoded cardiovascular magnetic resonance (veCMR) of the pulmonary artery and aorta (Qp/Qs). Imaging the secundum ASD en face could potentially enable direct flow measurement and, additionally, provide valuable information regarding ASD size, shape, location, and proximity to other structures. Methods: Patients referred for possible transcatheter ASD closure underwent a comprehensive standard evaluation including transesophageal and/or intracardiac echocardiography (ICE), and invasive oximetry. CMR was performed in parallel and included direct en face veCMR after an optimal double-oblique imaging plane was determined accounting for ASD flow direction and cardiac-cycle interatrial septal motion. We hypothesized that En face veCMR using an optimized imaging plane can accurately determine ASD flow, size, and morphology, and that it would provide information incremental to comprehensive standard evaluation.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date July 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Suspected Atrial Septal Defect (ASD) undergoing evaluation for possible transcatheter closure Exclusion Criteria: - Contraindications to magnetic resonance imaging - known sinus venosus or primum defects

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke Cardiovascular Magnetic Resonance Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

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