Atrial Septal Defect, Secundum Type Clinical Trial
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
| Verified date | July 2021 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 30, 2020 |
| Est. primary completion date | October 30, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 11 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Assiut University Hospital | Assiut | |
| Egypt | Ain Shams University Hospital | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Ayman khairy Mohamed |
Egypt,
Balci KG, Balci MM, Aksoy MM, Yilmaz S, Aytürk M, Dogan M, Yeter E, Akdemir R. Remodeling process in right and left ventricle after percutaneous atrial septal defect closure in adult patients. Turk Kardiyol Dern Ars. 2015 Apr;43(3):250-8. doi: 10.5543/tkd — View Citation
Bussadori C, Oliveira P, Arcidiacono C, Saracino A, Nicolosi E, Negura D, Piazza L, Micheletti A, Chessa M, Butera G, Dua JS, Carminati M. Right and left ventricular strain and strain rate in young adults before and after percutaneous atrial septal defect — View Citation
Lange A, Coleman DM, Palka P, Burstow DJ, Wilkinson JL, Godman MJ. Effect of catheter device closure of atrial septal defect on diastolic mitral annular motion. Am J Cardiol. 2003 Jan 1;91(1):104-8. — View Citation
Wu ET, Akagi T, Taniguchi M, Maruo T, Sakuragi S, Otsuki S, Okamoto Y, Sano S. Differences in right and left ventricular remodeling after transcatheter closure of atrial septal defect among adults. Catheter Cardiovasc Interv. 2007 May 1;69(6):866-71. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measuring of the biventricular geometrical changes before and after ASD device closure | 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. | 1-3 month | |
| Primary | Measure change from baseline in the biventricular function of the ASD group | 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. | 1-3 month | |
| Primary | Measure the biventricular geometry and function of the control group | The control group LV/RV geometry and function values will be evaluated by using 2D Transthoracic Echocardiography. | Baseline | |
| Primary | Measure the relationship between the geometrical and function changes and device size of the ASD group | 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. | 1-3 month |