Congenital Heart DefectsABSORB-VSDNCT07040579
Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
An observational study of Congenital Heart Defects and VSD, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Congenital Heart Defects, VSD
- What is being tested?
- transcatheter closure of outlet VSDs with bioabsorbable occluders
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 31 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients diagnosed with outlet ventricular septal defects who undergo transcatheter closure with bioabsorbable occluders
Who may be able to join
- Age ≥1 year and weight ≥10 kg
- Outlet VSD without ventricular malalignment
- Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography
- Written informed consent
Who cannot join
- Outlet VSD with a fibrous postero-inferior rim
- Concurrent cardiac conditions requiring surgical correction
- Severe pulmonary hypertension (PVR > 5 WU, assessed by right heart catheterization )
- Intracardiac thrombus
- Pregnancy
- Active systemic infection within 1 month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Liuliu Huang, MD, +8618577780131, dochuangllgxnn@gmail.com
Baoshi Zheng, MD, +8613977189015, Zhengbs25@vip.sina.com
About this study
Official title: Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.
Read the detailed description
Outflow-type ventricular septal defects (outlet VSDs) represent a challenging subset of congenital heart defects due to their association with progressive aortic valve prolapse and regurgitation. While surgical repair remains the gold standard, no reliable occluder has been available for transcatheter closure of this defect subtype.
The anatomical proximity of outlet VSDs to the aortic valve has historically limited transcatheter interventions. Conventional eccentric metal occluders require strict patient selection, typically being feasible only in cases with small defects and minimal aortic valve prolapse. Moreover, long-term concerns persist regarding metal devices' impact on aortic valve function.
Bioabsorbable occluders have been clinically available for perimembranous VSD closure. Their soft material properties minimize mechanical trauma to the aortic valve, while gradual resorption over time may eliminate permanent device-related complications. However, robust data regarding their efficacy, safety, and long-term impact on aortic valve function in outlet VSDs remain lacking.
This study aims to evaluate the short- and long-term outcomes of bioabsorbable occluder closure in outlet VSD patients, with a focus on defect closure rates and aortic valve function preservation.
- Conditions
- Congenital Heart Defects, VSD
- Being tested
- transcatheter closure of outlet VSDs with bioabsorbable occluders
- Keywords
- transcatheter, bioabsorbable occluder, outlet VSD
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter closure of outlet VSDs with bioabsorbable occludersDevice
Transcatheter closure of outlet ventricular septal defects using a bioabsorbable occluder (Shape Memory Alloy Ltd, Shanghai, China). Implantation is performed via femoral/transthoracic approach under echocardiographic guidance following standard interventional protocols.
| Study group | Role | What they receive |
|---|---|---|
| BioOccl-VSD | Patients with outlet ventricular septal defects undergoing transcatheter closure with bioabsorbable occluders. Receives: Device: transcatheter closure of outlet VSDs with bioabsorbable occluders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with procedural success
- Occluder in correct anatomical position
- Absence of major adverse events (all-cause mortality, all stroke, myocardial infarction, or re-hospitalization for device/procedure-related causes) 3) Residual shunt ≤ 2 mm and aortic regurgitation ≤ trace evaluated by transthoracic or transesophageal echocardiography
Measured: 12 months
Secondary outcomes (8)
Number of participants with technical success
Absence of mortality, correct positioning of the occluder into the proper anatomical location， aortic regurgitation≤ trace by transthoracic or transesophageal echocardiography
Measured: Intraprocedural
Number of participants with major adverse events
All-cause mortality, all stroke, myocardial infarction, re-hospitalization for device or procedure-related causes
Measured: 12/24/60 months
Closure Efficacy
1）Successful closure: Rate of successful VSD closure (residual shunt ≤2 mm) assessed by transthoracic or transesophageal echocardiography.
- Complete closure: Rate of complete closure (no residual shunt) assessed by transthoracic or transesophageal echocardiography.
Measured: Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Aortic regurgitation severity
Aortic regurgitation severity measured by transthoracic and/or transesophageal echocardiography. Assessment of aortic regurgitation severity according to current recommendations for valvular heart disease.
Measured: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Pulmonary regurgitation severity
Pulmonary regurgitation severity measured by transthoracic and/or transesophageal echocardiography. Assessment of pulmonary regurgitation severity according to current recommendations for valvular heart disease.
Measured: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Left ventricular outflow tract (LVOT) velocity and pressure gradient
Peak LVOT velocity (m/s) and maximum instantaneous pressure gradient (mmHg) measured by continuous-wave Doppler (CWD) echocardiography, using the simplified Bernoulli equation (ΔP = 4v²).
Measured: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Right ventricular outflow tract （RVOT）velocity and pressure gradient
Peak LVOT velocity (m/s) and maximum instantaneous pressure gradient (mmHg) measured by continuous-wave Doppler (CWD) echocardiography, using the simplified Bernoulli equation (ΔP = 4v²).
Measured: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Disc area quantification
Left and right disc areas are measured by transthoracic echocardiography (TTE) planimetry in parasternal short-axis (PSAX), apical long-axis (ALAX), and apical 5-chamber (A5C) views using QLAB 3DQ Advanced software (Philips). The mean disc area is derived from the average of three orthogonal transthoracic echocardiography measurements.
Measured: 72 hours post procedure, 1/3/6/12/24/60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Sep 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies 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
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liuliu Huang, MD, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040579
- Sponsor's protocol ID
- GXMU-VSDO-001
- Acronym
- ABSORB-VSD
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) would not be shared, according to local authority data privacy policy.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function
- ClinicalTrials.gov ID
- NCT07040579
- Acronym / sponsor ID
- ABSORB-VSD / GXMU-VSDO-001
- Conditions
- Congenital Heart Defects, VSD
- Keywords
- transcatheter, bioabsorbable occluder, outlet VSD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 27 Jun 2025 (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.
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.
Detailed description
Outflow-type ventricular septal defects (outlet VSDs) represent a challenging subset of congenital heart defects due to their association with progressive aortic valve prolapse and regurgitation. While surgical repair remains the gold standard, no reliable occluder has been available for transcatheter closure of this defect subtype.
The anatomical proximity of outlet VSDs to the aortic valve has historically limited transcatheter interventions. Conventional eccentric metal occluders require strict patient selection, typically being feasible only in cases with small defects and minimal aortic valve prolapse. Moreover, long-term concerns persist regarding metal devices' impact on aortic valve function.
Bioabsorbable occluders have been clinically available for perimembranous VSD closure. Their soft material properties minimize mechanical trauma to the aortic valve, while gradual resorption over time may eliminate permanent device-related complications. However, robust data regarding their efficacy, safety, and long-term impact on aortic valve function in outlet VSDs remain lacking.
This study aims to evaluate the short- and long-term outcomes of bioabsorbable occluder closure in outlet VSD patients, with a focus on defect closure rates and aortic valve function preservation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioOccl-VSD | – | Device: transcatheter closure of outlet VSDs with bioabsorbable occludersPatients with outlet ventricular septal defects undergoing transcatheter closure with bioabsorbable occluders. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients diagnosed with outlet ventricular septal defects who undergo transcatheter closure with bioabsorbable occluders
Key inclusion criteria (4 listed)
- Age ≥1 year and weight ≥10 kg
- Outlet VSD without ventricular malalignment
- Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography
- Written informed consent
Key exclusion criteria (6 listed)
- Outlet VSD with a fibrous postero-inferior rim
- Concurrent cardiac conditions requiring surgical correction
- Severe pulmonary hypertension (PVR > 5 WU, assessed by right heart catheterization )
- Intracardiac thrombus
- Pregnancy
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 |
|---|---|---|
| transcatheter closure of outlet VSDs with bioabsorbable occludersTranscatheter closure of outlet ventricular septal defects using a bioabsorbable occluder (Shape Memory Alloy Ltd, Shanghai, China). Implantation is performed via femoral/transthoracic approach under echocardiographic guidance following standard interventional protocols. | Device | BioOccl-VSD |
Primary outcome
Number of participants with procedural success
Time frame: 12 months
1. Occluder in correct anatomical position 2. Absence of major adverse events (all-cause mortality, all stroke, myocardial infarction, or re-hospitalization for device/procedure-related causes) 3) Residual shunt ≤ 2 mm and aortic regurgitation ≤ trace evaluated by transthoracic or transesophageal echocardiography
8 secondary outcomes
Number of participants with technical success
Time frame: Intraprocedural
Number of participants with major adverse events
Time frame: 12/24/60 months
Closure Efficacy
Time frame: Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Aortic regurgitation severity
Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Pulmonary regurgitation severity
Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Left ventricular outflow tract (LVOT) velocity and pressure gradient
Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Right ventricular outflow tract （RVOT）velocity and pressure gradient
Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months
Disc area quantification
Time frame: 72 hours post procedure, 1/3/6/12/24/60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) would not be shared, according to local authority data privacy policy.
Related trials for Congenital Heart Defects
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
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.
Liuliu Huang, MD principal investigator
First Affiliated Hospital of Guangxi Medical University
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 Congenital Heart Defects and VSD, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liuliu Huang, MD (+8618577780131, dochuangllgxnn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with procedural success (time frame: 12 months). 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 27 Jun 2025.