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

NCT ID: NCT01907971

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ebstein Anomaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ebstein anomaly

Patients with Ebstein anomaly

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Zürich

OTHER

Sponsor Role collaborator

Angela Oxenius

OTHER

Sponsor Role lead

Responsible Party

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Angela Oxenius

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christine H Attenhofer, Prof

Role: PRINCIPAL_INVESTIGATOR

Locations

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University Childrens Hospital

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Related Links

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Other Identifiers

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VentriPoint in Ebstein anomaly

Identifier Type: -

Identifier Source: org_study_id

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