NCT00498446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
Last Updated

October 26, 2023

Status Verified

July 1, 2007

First QC Date

July 9, 2007

Last Update Submit

October 24, 2023

Conditions

Atrial Septal Defect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected Atrial Septal Defect (ASD) undergoing evaluation for possible transcatheter closure

You may not qualify if:

  • Contraindications to magnetic resonance imaging
  • known sinus venosus or primum defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Cardiovascular Magnetic Resonance Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Thomson LE, Crowley AL, Heitner JF, Cawley PJ, Weinsaft JW, Kim HW, Parker M, Judd RM, Harrison JK, Kim RJ. Direct en face imaging of secundum atrial septal defects by velocity-encoded cardiovascular magnetic resonance in patients evaluated for possible transcatheter closure. Circ Cardiovasc Imaging. 2008 Jul;1(1):31-40. doi: 10.1161/CIRCIMAGING.108.769786.

    PMID: 19808512DERIVED

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Raymond J Kim, MD

    Duke Cardiovascular Magnetic Resonance Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

July 1, 2002

Study Completion

July 1, 2004

Last Updated

October 26, 2023

Record last verified: 2007-07

Locations

US(1)