Atrial Septal Defect, Secundum TypeNCT04091919
Assessment of LV/RV S and SR Before and After Percutaneous Closure of ASDs
An observational study of Atrial Septal Defect, Secundum Type, run by Ayman khairy Mohamed at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Atrial Septal Defect, Secundum Type
- What is being tested?
- 2D- Transthoracic Echocardiography (TTE)
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2019to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut University Hospital
Asyut, 71515
Ain Shams University Hospital
Cairo, 1181
About this study
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
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.
Read the 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.
- Conditions
- Atrial Septal Defect, Secundum Type
- Being tested
- 2D- Transthoracic Echocardiography (TTE)
- Keywords
- Left and right ventricular global longitudinal strain, ASD device closure
- Medical subject headings
- Atrial Septal Defect, Secundum Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D- Transthoracic Echocardiography (TTE)Diagnostic test
2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 2D- Transthoracic Echocardiography (TTE) | |
| Controlled group | Age matched controlled subjects without ASD Receives: Diagnostic Test: 2D- Transthoracic Echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3 month
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.
Measured: 1-3 month
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.
Measured: Baseline
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.
Measured: 1-3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Jan 2019
- Primary completion30 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial Septal Defect, Secundum TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayman khairy Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayman khairy Mohamed, Assiut University
- Investigators
- Areej AA Tammam Alkhateeb, Msc, Principal investigator, Assiut UniversityAlaa M Roushdy, MD,PhD, Principal investigator, Ain Shams UniversityAyman KM Hassan, MD,PhD, Study chair, Assiut UniversityHosam Hasan-Ali, MD, PhD, Study director, Assiut UniversityYehia T Kishk, MD, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091919
- Sponsor's protocol ID
- LV/RV S and SR with ASD device
- Status last verified
- Jul 2021
- First submitted
- 11 Sep 2019
- Last updated
- 15 Jul 2021
- Results posted
- No
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.
PubMed 12505587Bussadori 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.
PubMed 21615485Balci 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.
PubMed 25905996Wu 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.
PubMed 17390329
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04091919
- Acronym / sponsor ID
- LV/RV S and SR with ASD device
- Conditions
- Atrial Septal Defect, Secundum Type
- Keywords
- Left and right ventricular global longitudinal strain, ASD device closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ayman khairy MohamedUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Diagnostic Test: 2D- Transthoracic Echocardiography (TTE)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. |
| Controlled group | – | Diagnostic Test: 2D- Transthoracic Echocardiography (TTE)Age matched controlled subjects without ASD |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D- Transthoracic Echocardiography (TTE)2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging | Diagnostic test | ASD group, Controlled group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Results publication: PubMed 12505587Lange 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.
- Results publication: PubMed 21615485Bussadori 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.
- Results publication: PubMed 25905996Balci 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.
- Results publication: PubMed 17390329Wu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej AA Tammam Alkhateeb, Msc principal investigator
Assiut University
Alaa M Roushdy, MD,PhD principal investigator
Ain Shams University
Ayman KM Hassan, MD,PhD study chair
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Septal Defect, Secundum Type, run by Ayman khairy Mohamed at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring of the biventricular geometrical changes before and after ASD device closure (time frame: 1-3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091919, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.