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

Completed

• Conditions: Atrial Septal Defect, Secundum Type
• Interventions: Diagnostic Test: 2D- Transthoracic Echocardiography (TTE)

• Registration Number: NCT04091919
• Lead Sponsor: Ayman khairy Mohamed

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.

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD group	2D- Transthoracic Echocardiography (TTE)	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.
Controlled group	2D- Transthoracic Echocardiography (TTE)	Age matched controlled subjects without ASD

Primary Outcome Measures

Name	Time	Method
Measure change from baseline in the biventricular function of the ASD group	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.
Measure the biventricular geometry and function of the control group	Baseline	The control group LV/RV geometry and function values will be evaluated by using 2D Transthoracic Echocardiography.
Measuring of the biventricular geometrical changes before and after ASD device closure	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.
Measure the relationship between the geometrical and function changes and device size of the ASD group	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.

Trial Locations

Locations (2)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt

Assiut University Hospital; 🇪🇬 Assiut, Egypt