Assessment of Left and Right Ventricular Function in Patients With Ebstein Anomaly With Different Echocardiographic Methods

Ebstein Anomaly Clinical Trial

Official title:

Left Ventricular Function in Ebstein Anomaly: Assessment by 3D Echocardiography and Speckle Tracking. Assessment and Validation of the Right Ventricle by VentriPoint Method.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907971
• Other study ID #: VentriPoint in Ebstein anomaly
• Status: Completed
• Phase: N/A
• First received: July 22, 2013
• Last updated: May 26, 2015
• Start date: August 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2014
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ebstein anomaly

• male and female 11 years to 80 years of age

• Unoperated or operated on the heart, including 1 1/2 chamber palliation

• Wolff-Parkinson-White Syndrome

Exclusion Criteria:

• moderate or severe mitral valve insufficiency, moderate or severe aortic insufficiency, moderate or severe aortic stenosis

• Univentricular palliation (Fontan)

• St.n. myectomy of the left ventricle

• Concomitant L-transposition of the great arteries

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Ebstein Anomaly

Locations

Country	Name	City	State
Switzerland	University Childrens Hospital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Angela Oxenius	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Correlation of findings with clinical symptoms	Correlation with the severity of tricuspid regurgitation, the clinical symptoms, size and function of the right ventricle	1 year	No

External Links

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