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.
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05225311 -
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
|
||
| Completed |
NCT02914171 -
Study of Autologous Bone Marrow Derived Mononuclear Cells for Treatment of Ebstein Anomaly
|
Phase 1 |