CompletedNot Applicable

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

Egypt50 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Measuring of the biventricular geometrical changes before and after ASD device closure

Timeframe: 1-3 month

Measure change from baseline in the biventricular function of the ASD group

Timeframe: 1-3 month

Measure the biventricular geometry and function of the control group

Timeframe: Baseline

Measure the relationship between the geometrical and function changes and device size of the ASD group

Timeframe: 1-3 month

Trial details

NCT IDNCT04091919

SponsorAyman khairy Mohamed

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-10-30

View on ClinicalTrials.gov More Atrial Septal Defect, Secundum Type trials

Plain-language summary

Who can participate

Age range11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measuring of the biventricular geometrical changes before and after ASD device closure

Timeframe: 1-3 month

Measure change from baseline in the biventricular function of the ASD group

Timeframe: 1-3 month

Measure the biventricular geometry and function of the control group

Timeframe: Baseline

Measure the relationship between the geometrical and function changes and device size of the ASD group

Timeframe: 1-3 month