Ebstein AnomalyNCT01907971
Assessment of Left and Right Ventricular Function in Patients With Ebstein Anomaly With Different Echocardiographic Methods
An observational study of Ebstein Anomaly, run by Angela Oxenius at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 11 to 80 years
- Conditions the study is for
- Ebstein Anomaly
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ebstein anomaly patients of the Zurich Area followed by primary care center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Childrens Hospital
Zurich, Canton of Zurich, 8032
About this study
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.
Read more
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.
- Conditions
- Ebstein Anomaly
- Medical subject headings
- Ebstein Anomaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ebstein anomaly | Patients with Ebstein anomaly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Correlation of findings with clinical symptoms
Correlation with the severity of tricuspid regurgitation, the clinical symptoms, size and function of the right ventricle
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebstein AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela Oxenius
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor-investigator, Angela Oxenius, University Children's Hospital, Zurich
- Investigators
- Christine H Attenhofer, Prof, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907971
- Sponsor's protocol ID
- VentriPoint in Ebstein anomaly
- Status last verified
- Mar 2014
- First submitted
- 22 Jul 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01907971
- Acronym / sponsor ID
- VentriPoint in Ebstein anomaly
- Conditions
- Ebstein Anomaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Angela OxeniusUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ebstein anomaly | – | –Patients with Ebstein anomaly |
Who may qualify
- Ages
- 11 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ebstein anomaly patients of the Zurich Area followed by primary care center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation of findings with clinical symptoms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Related InfoLink provided by the sponsor.
Related trials for Ebstein Anomaly
RecruitingObservational study
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
Ebstein Anomaly, Tricuspid Valve Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine H Attenhofer, Prof principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebstein Anomaly, run by Angela Oxenius at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular volume (ml/m2) and function by VentriPoint. Structural myocardial changes in the left ventricle (Strain). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.