Atrial Septal DefectNCT06139679
Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study
An observational study of Atrial Septal Defect, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- ASD closure with fenestrated/non-fenestrated patch
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2022to 30 Nov 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ASD secundum with pulmonary hypertension of all age groups who underwent surgical closure of ASD in Dr. Soetomo General Academic Hospital within January 2017 - October 2021
Who may be able to join
- Patients with ASD secundum and pulmonary hypertension with complete preoperative and postoperative echocardiography (LVIDd and LVIDs) data
- Patients with ASD secundum and pulmonary hypertension with complete preoperative but incomplete postoperative echocardiography (LVIDd and LVIDs) data, but willing to present upon invitation to complete missing postoperative data
Who cannot join
- Patients with ASD secundum and pulmonary hypertension who are unwilling to participate in the study, or in a condition that prevents the patient to present for echocardiographic evaluation
- Patients with incomplete medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement In Left Ventricular Diameter After Closure Of Atrial Septal Defect With Fenestrated Patch: A Cross-sectional Study
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.
Read the detailed 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.
- Conditions
- Atrial Septal Defect
- Being tested
- ASD closure with fenestrated/non-fenestrated patch
- Keywords
- Left Ventricle Diameter, Atrial septal defect closure, Fenestrated patch
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD closure with fenestrated/non-fenestrated patchProcedure or surgery
A PTFE patch is used to surgically close the interatrial defect. If closure with fenestrated patch is deemed necessary, a small opening is created on the patch
| Study group | Role | What they receive |
|---|---|---|
| Fenestrated | Patients with ASD who underwent surgical closure of ASD with fenestrated patch Receives: Procedure: ASD closure with fenestrated/non-fenestrated patch | |
| Non-fenestrated | Patients with ASD who underwent surgical closure of ASD with non-fenestrated patch Receives: Procedure: ASD closure with fenestrated/non-fenestrated patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in left ventricular diameter during systole and diastole
The change in left ventricular diameter during both systole and diastole is measured preoperatively and postoperatively
Measured: January 2017 - October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Mar 2022
- Primary completion31 Aug 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, dr. Heroe Soebroto, Sp.B, Sp.BTKV, Subsp.JPK(K), Dr. Soetomo General Hospital
- Investigators
- Heroe Soebroto, Principal investigator, Department of Thoracic, Cardiac, and Vascular Surgery, Dr. Soetomo General Hospital, Surabaya, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139679
- Sponsor's protocol ID
- 1148/110/3/XII/2021
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement In Left Ventricular Diameter After Closure Of Atrial Septal Defect With Fenestrated Patch: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06139679
- Acronym / sponsor ID
- 1148/110/3/XII/2021
- Conditions
- Atrial Septal Defect
- Keywords
- Left Ventricle Diameter, Atrial septal defect closure, Fenestrated patch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 18 Nov 2023 (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.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenestrated | – | Procedure: ASD closure with fenestrated/non-fenestrated patchPatients with ASD who underwent surgical closure of ASD with fenestrated patch |
| Non-fenestrated | – | Procedure: ASD closure with fenestrated/non-fenestrated patchPatients with ASD who underwent surgical closure of ASD with non-fenestrated patch |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ASD secundum with pulmonary hypertension of all age groups who underwent surgical closure of ASD in Dr. Soetomo General Academic Hospital within January 2017 - October 2021
Key inclusion criteria (2 listed)
- Patients with ASD secundum and pulmonary hypertension with complete preoperative and postoperative echocardiography (LVIDd and LVIDs) data
- Patients with ASD secundum and pulmonary hypertension with complete preoperative but incomplete postoperative echocardiography (LVIDd and LVIDs) data, but willing to present upon invitation to complete missing postoperative data
Key exclusion criteria (2 listed)
- Patients with ASD secundum and pulmonary hypertension who are unwilling to participate in the study, or in a condition that prevents the patient to present for echocardiographic evaluation
- Patients with incomplete medical records
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 |
|---|---|---|
| ASD closure with fenestrated/non-fenestrated patchA PTFE patch is used to surgically close the interatrial defect. If closure with fenestrated patch is deemed necessary, a small opening is created on the patch | Procedure or surgery | Fenestrated, Non-fenestrated |
Primary outcome
Improvement in left ventricular diameter during systole and diastole
Time frame: January 2017 - October 2021
The change in left ventricular diameter during both systole and diastole is measured preoperatively and postoperatively
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 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Heroe Soebroto principal investigator
Department of Thoracic, Cardiac, and Vascular Surgery, Dr. Soetomo General Hospital, Surabaya, Indonesia
1 site 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, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 2 inclusion and 2 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
Improvement in left ventricular diameter during systole and diastole (time frame: January 2017 - October 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.