Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06139679 |
| Other study ID # |
1148/110/3/XII/2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Dr. Soetomo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses
a clinical challenge on whether or not to close the defect. Closing the defect increases the
risk of low cardiac output syndrome (LCOS), while leaving the defect open may eventually lead
to irreparable shunt reversal, hypoxemia, and death. The implementation of a fenestrated
patch may halt LCOS while adding volume to the left heart.
Methods: this is an analytical observational study involving patients with ostium secundum
defect with PH who were operated on in Dr. Soetomo Hospital between January 2017 and October
2021. The aim of this study is to evaluate the improvement in left ventricular size during
both systole and diastole.
Description:
Atrial septal defect (ASD) is one of the most common congenital heart diseases. It is
typically characterized by a left-to-right shunt which results in volume overload of the
right ventricle and overcirculation of the pulmonary vascularization (le Gloan et al., 2018).
This may further result in arrhythmia, right ventricular dysfunction, and pulmonary
hypertension (PH). Pulmonary hypertension is caused by endothelial dysfunction, remodelling
of the pulmonary vascularization, which increases pulmonary vascular resistance, and
eventually causes shunt reversal into right-to-left (Eisenmenger's syndrome). At this point,
closure of the defect is contraindicated.
Small LV, although less extensively studied than dilated LV, also implies impaired LV
function. Small LV means less tolerance to volume overload, which in turn impairs cardiac
output and presents higher risk of heart failure and mortality (Saito et al., 2021).
ASD closure in cases with severe pulmonary hypertension (PH) presents a clinical challenge.
Complete closure may cause pulmonary hypertensive crisis and low cardiac output syndrome;
however, if left untreated, the disease progresses, the pulmonary vascular resistance
increases, which may also lead to Eisenmenger's syndrome and shunt reversal. Today, this
condition is treated with fenestrated closure, either with patch or fenestrated septal
occluder. The fenestration is hypothesized to provide protective effect against pulmonary
hypertensive crisis because it allows blood to flow from right to left heart. The added
volume into the left heart is then, hypothesized, to provide volume training for the left
heart, mainly in the case of small LV. Therefore, this study aims to evaluate the effect of
fenestrated closure compared to non- fenestrated closure to the left ventricular size at
systole and diastole.
