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Assessment of LV/RV S and SR Before and After Percutaneous Closure of ASDs

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ClinicalTrials.gov Identifier: NCT04091919
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ayman Khairy Mohamed Hassan, Assiut University

Brief Summary:
The effect of Atrial Septal Defect (ASD) closure by using larger devices on the improvement in biventricular function remains an area of active research. Therefore, the aim of the current study is to assess the degree of improvement in biventricular dimensions and function by using 2-Dimensional echocardiography derived Strain and Strain Rate and Tissue Doppler. Moreover, to identify the relationship between the left and right ventricular systolic and diastolic function and device size.

Condition or disease Intervention/treatment
Atrial Septal Defect, Secundum Type Diagnostic Test: 2D- Transthoracic Echocardiography (TTE)

Detailed Description:
In most echocardiographic studies, left ventricle (LV) systolic function was normal in the patients with ASD and only a few cases had a reduced LV ejection fraction with severe right ventricle (RV) volume overload. The device closure of ASD increases immediately the blood flow to the left ventricle and may unmask subtle abnormalities in systolic and diastolic function. Currently, clinical research in cardiac mechanics is moving from short- and long-axis LV and RV function and ejection fraction to two and three- dimensional (2D, 3D) ventricular deformation studies (Strain and Strain Rate quantification). These methods are independent of ventricular geometry and allow quantification of myocardial motion and deformation in different directions (longitudinal, radial, and circumferential), while conventional methods mainly rely on the assessment of radial function. Strain imaging has also been used to demonstrate that patients who underwent device closure of an ASD had better LV and RV longitudinal deformation than patients who underwent surgical closure of an ASD. However, the effect of device size on the LV systolic and diastolic function is still under investigations. For all these reasons the researchers intend to measure RV and LV haemodynamic changes by 2-D Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain quantification in ASD before and after transcatheter closure with special emphasis on the assessment of the relationship between device size and biventricular systolic and LV diastolic function.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Left and Right Ventricular Strain and Strain Rate Before and After Percutaneous Closure of Atrial Septal Defects in Adults and Adolescents
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
ASD group
Isolated ostium Secundum ASD patients who are involving in this study have been already selected for intervention before the starting time of the study. The ASD patients who will be scheduled for transcatheter closure have either haemodynamically significant shunt fraction (Qp/Qs > 1.5) or echocardiographic signs of right heart dilation or RV volume overload and pulmonary hypertension related symptoms. 2-D TTE derived Tissue Doppler and Strain Imaging will be done for all patients at baseline, 24 hours and 1-3 month post-procedure. Correlation between the device size and echocardiographic variables will be performed. Comparison between the results of the 2D-TTE derived Strain Imaging procedures will be done between baseline data and those obtained one day after the procedure and at one month follow up.
Diagnostic Test: 2D- Transthoracic Echocardiography (TTE)
2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging

Controlled group
Age matched controlled subjects without ASD
Diagnostic Test: 2D- Transthoracic Echocardiography (TTE)
2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging




Primary Outcome Measures :
  1. Measuring of the biventricular geometrical changes before and after ASD device closure [ Time Frame: 1-3 month ]
    The LV and RV geometrical changes of the ASD group will be evaluated by using standard 2D Transthoracic Echocardiography before, 24 hours and one month after transcatheter ASD device closure procedure. The geometrical changes include LV and RV dimensions, pressure and wall masses.

  2. Measure change from baseline in the biventricular function of the ASD group [ Time Frame: 1-3 month ]
    Change from baseline in Biventricular systolic function and LV diastolic function of the ASD group will be measured by using 2D Echocardiography (derived Strain, Strain Rate and Tissue Doppler Imaging) at 24 hours and one month after transcatheter ASD device closure procedure.

  3. Measure the biventricular geometry and function of the control group [ Time Frame: Baseline ]
    The control group LV/RV geometry and function values will be evaluated by using 2D Transthoracic Echocardiography.

  4. Measure the relationship between the geometrical and function changes and device size of the ASD group [ Time Frame: 1-3 month ]
    The waist size of the selected device that will be used in transcatheter closure of the ASD will be documented according to the diameter of defect by using Transoesophageal Echocardiography before and during the closure procedure. Then, the relationship between the LV/RV geometrical and function changes after transcatheter closure and the used device size will be measured.



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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

The study includes two groups: 1. Patients with isolated Secundum ASDs who are referred for possible elective transcatheter closure of the defects. Comparison between the results of the haemodynamic 2D echocardiography derived Strain and Strain Rate imaging procedure will be done as follow:

a. Echo 1 - performed just before the procedure b. Echo 2 - performed the day after the procedure c. Echo 3 - performed 1-3 months following the procedure

2. Control group: age and gender-matched healthy subjects are being examined to assess their LV and RV haemodynamic parameters and strain results and compare these data with the study group.

Criteria

Inclusion Criteria:

  • All ASD patients who have been already selected and suitable for intervention before the starting time of the study. The criteria for ASD intervention are either haemodynamically significant shunt fraction (Qp/Qs > 1.5) or echocardiographic signs of right heart dilation or RV volume overload and pulmonary hypertension related symptoms.

Exclusion Criteria:

  • Patients with a large stretched Secundum ASD ≥ 36 mm, those with insufficient ASD rims (except the aortic rim), sinus venosus or primum type ASD, irreversible pulmonary hypertension, other associated structural heart diseases, coronary artery disease, LV systolic dysfunction, atrial fibrillation, or hypertension.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091919


Contacts
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Contact: Areej AA Tammam Alkhateeb, Msc +201023858689 areejalkhateeb.cardio@gmail.com, areej.tammam@kcl.ac.uk, areejalkhateeb@med.svu.edu.eg
Contact: Alaa M Roushdy, MD, PhD +201223418875 alaa244@yahoo.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71515
Contact: Areej AA Tammam ALkhateeb, Msc    +201023858689    areejalkhateeb.cardio@gmail.com   
Principal Investigator: Areej AA Tammam Alkhateeb, Msc         
Ain Shams University Hospital Recruiting
Cairo, Egypt, 1181
Contact: Alaa M Roushdy, MD,PhD    +201223418875    alaa244@yahoo.com   
Sponsors and Collaborators
Ayman Khairy Mohamed Hassan
Investigators
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Principal Investigator: Areej AA Tammam Alkhateeb, Msc Assiut University
Principal Investigator: Alaa M Roushdy, MD,PhD Ain Shams University
Study Chair: Ayman KM Hassan, MD,PhD Assiut University
Study Director: Hosam Hasan-Ali, MD, PhD Assiut University
Study Director: Yehia T Kishk, MD, PhD Assiut University
Publications of Results:
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Responsible Party: Ayman Khairy Mohamed Hassan, Clinical Professor, Assiut University
ClinicalTrials.gov Identifier: NCT04091919    
Other Study ID Numbers: LV/RV S and SR with ASD device
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by Ayman Khairy Mohamed Hassan, Assiut University:
Left and right ventricular global longitudinal strain
ASD device closure
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities