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

July 14, 2021 updated by: Ayman khairy Mohamed

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university hospital
      • Cairo, Egypt, 1181
        • Ain Shams University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 2D- Transthoracic Echocardiography (TTE)
2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging
Controlled group
Age matched controlled subjects without ASD
Diagnostic test: 2D- Transthoracic Echocardiography (TTE)
2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging

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
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
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.
1-3 month
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.
Baseline
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.
1-3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayman khairy Mohamed

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

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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