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

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.

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Key information

Conditions

Ebstein Anomaly Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

11 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Childrens Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Right ventricular volume (ml/m2) and function by VentriPoint. Structural myocardial changes in the left ventricle (Strain).

Time frame: 1 year

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.

Secondary outcomes

Correlation of findings with clinical symptoms

Time frame: 1 year

Correlation with the severity of tricuspid regurgitation, the clinical symptoms, size and function of the right ventricle

Sponsors and collaborators

Lead sponsor

Angela Oxenius

Other

Collaborators

University Hospital, Zürich

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Jul 25, 2013
Registry last updated: May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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