Clinical trial NCT04091919: Assessment of LV/RV S and SR Before and After Percutaneous Closure of ASDs
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Septal Defect, Secundum Type
Keywords: Left and right ventricular global longitudinal strain
ASD device closure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Measuring of the biventricular geometrical changes before and after ASD device closure
timeFrame: 1-3 month
measure: Measure change from baseline in the biventricular function of the ASD group
timeFrame: 1-3 month
measure: Measure the biventricular geometry and function of the control group
timeFrame: Baseline
measure: Measure the relationship between the geometrical and function changes and device size of the ASD group
timeFrame: 1-3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Assiut University
name: Areej AA Tammam Alkhateeb, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Alaa M Roushdy, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ayman KM Hassan, MD,PhD
role: STUDY_CHAIR
affiliation: Assiut University
name: Hosam Hasan-Ali, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Yehia T Kishk, MD, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/s0002-9149(02)03013-8. No abstract available.
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 closure. Echocardiography. 2011 Aug;28(7):730-7. doi: 10.1111/j.1540-8175.2011.01434.x. Epub 2011 May 25.
citation: Balci KG, Balci MM, Aksoy MM, Yilmaz S, Ayturk 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/tkda.2015.57106.
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. doi: 10.1002/ccd.21075.