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Left Ventricular Function in Ebstein Anomaly: Assessment by 3D Echocardiography and Speckle Tracking. Assessment and Validation of the Right Ventricle by VentriPoint Method.
Sponsor study identifier
observational
18
1 country
1
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
January 2015
Actual (reported)Ebstein anomaly is a rare congenital heart disease. It encompasses abnormalities of the tricuspid valve, the right atrium and the right ventricle (RV). Currently, cardiac magnetic resonance imaging (MRI) is considered the method of choice for the assessment of RV volume and function. To evaluate the right heart function VentriPoint method was designed to assess the RV in a fraction of the time, resulting in better efficacy and lower costs. VentriPoint is approved for Tetralogy of Fallot patients as well as patients with systemic RV in d-transposition of the great arteries. This method uses 2 dimensional standard ultrasound views linked to a VentriPoint Medical Systems unit. After acquisition, the physician identifies anatomical landmarks with dots on a number of the 2D ultrasound views through the heart. With a sensor (magnetic tracking system: GPS) on the ultrasound probe we know where the 2D plane is in 3D space. In this way the precise anatomical landmark is located in 3D space. The aim of the present study is to assess the feasibility, reliability and accuracy of the echocardiographic knowledge-based 3D reconstruction method to measure RV volume and function in patients with Ebstein anomaly. The accuracy of the method will be assessed by comparison with measurements obtained by cardiac MRI. In addition to the right ventricle the investigators want to assess the left ventricular function in patients with Ebstein anomaly in this study. By using speckle tracking echocardiography the investigators would like to investigate on the left ventricular contractility, rotation and synchrony of the left ventricle together with the RV. Not seldom the left ventricle is neglected in a patient with Ebstein anomaly by impressive findings of the right ventricle. Changes in the myocardial left ventricular structure (non compaction) are also described and may have negative impact on the function. The investigators want to analyze 25-30 patients with Ebstein anomaly including children starting at 11 years of age.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 22, 2013
Actual (reported)July 25, 2013
Actual (reported)August 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)January 2015
Actual (reported)Right ventricular volume (ml/m2) and function by VentriPoint. Structural myocardial changes in the left ventricle (Strain).
Comparison of the VentriPoint findings with measurements obtained by cardiac MRI. Structural changes of the left ventricle by echocardiography as well as ventricular longitudinal deformation in strain value by speckle tracking echocardiography.
1 year
Correlation of findings with clinical symptoms
1 year
Patients with Ebstein anomaly
Ebstein anomaly patients of the Zurich Area followed by primary care center
University Childrens Hospital
Zurich, Canton of Zurich, 8032, Switzerland
Christine H Attenhofer, Prof
18 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2013
First Posted
July 25, 2013
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
May 27, 2015
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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