Completed

NCT Number: NCT04091919

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

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.

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Key information

Conditions

Atrial Septal Defect, Secundum Type

Age range

11 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University Hospital, Asyut, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2D- Transthoracic Echocardiography (TTE)

Diagnostic Test

2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging

Primary outcomes

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.
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.
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.
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.

Sponsors and collaborators

Lead sponsor

Ayman khairy Mohamed

Other

Registry information

Official study title

Assessment of Left and Right Ventricular Strain and Strain Rate Before and After Percutaneous Closure of Atrial Septal Defects in Adults and Adolescents

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 17, 2019
Registry last updated: Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.