- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04091919
Assessment of LV/RV S and SR Before and After Percutaneous Closure of ASDs
Assessment of Left and Right Ventricular Strain and Strain Rate Before and After Percutaneous Closure of Atrial Septal Defects in Adults and Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71515
- Assiut university hospital
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Cairo, Egypt, 1181
- Ain Shams University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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ASD group
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.
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2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging
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Controlled group
Age matched controlled subjects without ASD
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2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring of the biventricular geometrical changes before and after ASD device closure
Time Frame: 1-3 month
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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.
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1-3 month
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Measure change from baseline in the biventricular function of the ASD group
Time Frame: 1-3 month
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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.
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1-3 month
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Measure the biventricular geometry and function of the control group
Time Frame: Baseline
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The control group LV/RV geometry and function values will be evaluated by using 2D Transthoracic Echocardiography.
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Baseline
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Measure the relationship between the geometrical and function changes and device size of the ASD group
Time Frame: 1-3 month
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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.
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1-3 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Areej AA Tammam Alkhateeb, Msc, Assiut University
- Principal Investigator: Alaa M Roushdy, MD,PhD, Ain Shams University
- Study Chair: Ayman KM Hassan, MD,PhD, Assiut University
- Study Director: Hosam Hasan-Ali, MD, PhD, Assiut University
- Study Director: Yehia T Kishk, MD, PhD, Assiut University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LV/RV S and SR with ASD device
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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