ASD - Atrial Septal DefectPhase 4NCT07273227
A Multicenter Randomized Controlled Trial of Echocardiography-Guided Atrial Septal Defect Closure Performed in a Mobile Surgical Unit
A Phase 4 study testing Conventional Operating Room Echocardiography-guided ASD closure Group in people with ASD - Atrial Septal Defect, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Cardiovascular disease remains a major threat to global health, and structural heart disease which encompassing congenital heart defects, valvular disease, and cardiomyopathies constitutes a substantial proportion of its burden. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- ASD - Atrial Septal Defect
- What is being tested?
- Conventional Operating Room Echocardiography-guided ASD closure Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to 31 Jul 2028
- Phase
- Phase 4
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≥8 years and able to undergo percutaneous intervention under local anesthesia.
- Diagnosed with secundum ASD with a defect diameter of ≥6 mm and ≤36 mm, accompanied by right-sided volume overload.
- Anatomical features suitable for transcatheter closure: the distance from the defect rim to the coronary sinus, superior vena cava, inferior vena cava, and pulmonary veins is ≥5 mm; and the distance to the mitral valves is ≥7 mm.
Who cannot join
- Presence of primum ASD or sinus venosus ASD.
- Infective endocarditis or intracardiac thrombus.
- ASD with right-to-left shunting.
- Concomitant intracardiac anomalies requiring simultaneous surgical repair.
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
Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
Beijing, Beijing Municipality, 100037
Cheng Wang, MD.PhD, 18610945896, zdwangcheng@outlook.com
About this study
Cardiovascular disease remains a major threat to global health, and structural heart disease which encompassing congenital heart defects, valvular disease, and cardiomyopathies constitutes a substantial proportion of its burden. Atrial septal defect (ASD) is among the most common congenital heart conditions, occurring in approximately 1.6 per 1,000 live births. Percutaneous closure of ASD has become the standard treatment due to its minimally invasive nature and proven efficacy. However, conventional closure procedures rely heavily on fluoroscopic guidance and iodinated contrast, which carry risks of radiation exposure, contrast-related harm, and limit applicability in specific patient groups. Moreover, such procedures must be performed in catheterization laboratories equipped with digital subtraction angiography systems.
To overcome these limitations, our team has spent over a decade developing a fully ultrasound-guided, radiation-free, contrast-free percutaneous intervention system-an original Chinese innovation that has pioneered "no incision, no fluoroscopy, and no general anesthesia" treatment for structural heart disease. This methodology has evolved into a comprehensive technical system and has been successfully applied to ASD, PFO, ventricular septal defect (VSD), patent ductus arteriosus (PDA), and several valvular disorders. It has been recognized by national clinical guidelines (2017), awarded the Chinese Medical Association First-Class Science and Technology Award (2022), and honored by the World Health Organization Innovation Award.
Read more
Building upon the unique advantages of ultrasound-only guidance, we further developed a Mobile Surgical Vehicle. This mobile surgical unit integrates ultrasound imaging, sterilization, monitoring, and anesthesia equipment, enabling true "hospital-free" procedures for underserved regions lacking large medical devices. Early applications in remote areas of Southwest China and Belt-and-Road countries have demonstrated promising safety and feasibility.
Nevertheless, high-quality clinical evidence evaluating this mobile platform for ASD closure is lacking. To address this gap, we propose a multicenter randomized controlled trial to demonstrate that mobile-platform ultrasound-guided closure is non-inferior to conventional in-hospital ultrasound-guided procedures. This study will also refine methodology, workflow, and safety protocols for mobile interventional therapy. Its findings will provide essential evidence supporting this original Chinese technology, expand its international impact, and enable broader access for patients in remote regions.
- Conditions
- ASD - Atrial Septal Defect
- Being tested
- Mobile Surgical Vehicle Echocardiography-guided ASD closure Group, Conventional Operating Room Echocardiography-guided ASD closure Group
- Keywords
- echocardiography-guided, percutaneous intervention, atrial septal defect, mobile surgical vehicle, mobile surgical unit
- 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.
Mobile Surgical Vehicle Echocardiography-guided ASD closure GroupOther
Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed inside a mobile surgical vehicle.
Conventional Operating Room Echocardiography-guided ASD closure GroupOther
Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Surgical Vehicle Echocardiography-guided ASD closure Group | Experimental | Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed inside a mobile surgical vehicle. Receives: Other: Mobile Surgical Vehicle Echocardiography-guided ASD closure Group |
| Conventional Operating Room Echocardiography-guided ASD closure Group | Active comparator | Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room. Receives: Other: Conventional Operating Room Echocardiography-guided ASD closure Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint events
Composite endpoint events at 30 days after procedure, including failure of ultrasound-guided closure (conversion to fluoroscopy-guided intervention or open-heart surgery), residual shunt >2 mm, device embolization or migration, new-onset arrhythmia, bleeding, and infection.
Measured: at 30 days after the procedure
Secondary outcomes (9)
failure of ultrasound-guided closure (conversion to fluoroscopy-guided intervention or open-heart surgery)
failure of ultrasound-guided closure (conversion to fluoroscopy-guided intervention or open-heart surgery)
Measured: immediately after the procedure
residual shunt >2 mm
residual shunt >2 mm under echocardiography
Measured: at 30 days after the procedure
device embolization or migration
new device embolization or migration after procedure
Measured: at 30 days after the procedure
new-onset arrhythmia
new-onset arrhythmia after procedure
Measured: at 30 days after the procedure
bleeding
new bleeding after the procedure
Measured: at 30 days after the procedure
infection
new infection after procedure
Measured: at 30 days after the procedure
Composite endpoint events at 1 year
Composite endpoint events at 1 year after procedure, including failure of ultrasound-guided closure (conversion to fluoroscopy-guided intervention or open-heart surgery), residual shunt >2 mm, device embolization or migration, new-onset arrhythmia, bleeding, and infection.
Measured: at 1 year after the procedure
length of postoperative hospital stay
length of postoperative hospital stay
Measured: at discharge (within 10 days after the procedure)
hospitalization costs
hospitalization cost
Measured: at discharge (within 10 days after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start19 Dec 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASD - Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cheng Wang, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273227
- Sponsor's protocol ID
- 2024-2488
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Echocardiography-Guided Atrial Septal Defect Closure Performed in a Mobile Surgical Unit
- ClinicalTrials.gov ID
- NCT07273227
- Acronym / sponsor ID
- 2024-2488
- Conditions
- ASD - Atrial Septal Defect
- Keywords
- echocardiography-guided, percutaneous intervention, atrial septal defect, mobile surgical vehicle, mobile surgical unit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 19 Dec 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Dec 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.
Cardiovascular disease remains a major threat to global health, and structural heart disease which encompassing congenital heart defects, valvular disease, and cardiomyopathies constitutes a substantial proportion of its burden. Atrial septal defect (ASD) is among the most common congenital heart conditions, occurring in approximately 1.6 per 1,000 live births. Percutaneous closure of ASD has become the standard treatment due to its minimally invasive nature and proven efficacy. However, conventional closure procedures rely heavily on fluoroscopic guidance and iodinated contrast, which carry risks of radiation exposure, contrast-related harm, and limit applicability in specific patient groups. Moreover, such procedures must be performed in catheterization laboratories equipped with digital subtraction angiography systems.
To overcome these limitations, our team has spent over a decade developing a fully ultrasound-guided, radiation-free, contrast-free percutaneous intervention system-an original Chinese innovation that has pioneered "no incision, no fluoroscopy, and no general anesthesia" treatment for structural heart disease. This methodology has evolved into a comprehensive technical system and has been successfully applied to ASD, PFO, ventricular septal defect (VSD), patent ductus arteriosus (PDA), and several valvular disorders. It has been recognized by national clinical guidelines (2017), awarded the Chinese Medical Association First-Class Science and Technology Award (2022), and honored by the World Health Organization Innovation Award.
Building upon the unique advantages of ultrasound-only guidance, we further developed a Mobile Surgical Vehicle. This mobile surgical unit integrates ultrasound imaging, sterilization, monitoring, and anesthesia equipment, enabling true "hospital-free" procedures for underserved regions lacking large medical devices. Early applications in remote areas of Southwest China and Belt-and-Road countries have demonstrated promising safety and feasibility.
Nevertheless, high-quality clinical evidence evaluating this mobile platform for ASD closure is lacking. To address this gap, we propose a multicenter randomized controlled trial to demonstrate that mobile-platform ultrasound-guided closure is non-inferior to conventional in-hospital ultrasound-guided procedures. This study will also refine methodology, workflow, and safety protocols for mobile interventional therapy. Its findings will provide essential evidence supporting this original Chinese technology, expand its international impact, and enable broader access for patients in remote regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Surgical Vehicle Echocardiography-guided ASD closure Group | Experimental | Other: Mobile Surgical Vehicle Echocardiography-guided ASD closure GroupPatients undergo ultrasound-guided percutaneous atrial septal defect closure performed inside a mobile surgical vehicle. |
| Conventional Operating Room Echocardiography-guided ASD closure Group | Active comparator | Other: Conventional Operating Room Echocardiography-guided ASD closure GroupPatients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥8 years and able to undergo percutaneous intervention under local anesthesia.
- Diagnosed with secundum ASD with a defect diameter of ≥6 mm and ≤36 mm, accompanied by right-sided volume overload.
- Anatomical features suitable for transcatheter closure: the distance from the defect rim to the coronary sinus, superior vena cava, inferior vena cava, and pulmonary veins is ≥5 mm; and the distance to the mitral valves is ≥7 mm.
Key exclusion criteria (4 listed)
- Presence of primum ASD or sinus venosus ASD.
- Infective endocarditis or intracardiac thrombus.
- ASD with right-to-left shunting.
- Concomitant intracardiac anomalies requiring simultaneous surgical repair.
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 |
|---|---|---|
| Mobile Surgical Vehicle Echocardiography-guided ASD closure GroupPatients undergo ultrasound-guided percutaneous atrial septal defect closure performed inside a mobile surgical vehicle. | Other | Mobile Surgical Vehicle Echocardiography-guided ASD closure Group |
| Conventional Operating Room Echocardiography-guided ASD closure GroupPatients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room. | Other | Conventional Operating Room Echocardiography-guided ASD closure Group |
Primary outcome
composite endpoint events
Time frame: at 30 days after the procedure
Composite endpoint events at 30 days after procedure, including failure of ultrasound-guided closure (conversion to fluoroscopy-guided intervention or open-heart surgery), residual shunt >2 mm, device embolization or migration, new-onset arrhythmia, bleeding, and infection.
9 secondary outcomes
failure of ultrasound-guided closure (conversion to fluoroscopy-guided intervention or open-heart surgery)
Time frame: immediately after the procedure
residual shunt >2 mm
Time frame: at 30 days after the procedure
device embolization or migration
Time frame: at 30 days after the procedure
new-onset arrhythmia
Time frame: at 30 days after the procedure
bleeding
Time frame: at 30 days after the procedure
infection
Time frame: at 30 days after the procedure
Composite endpoint events at 1 year
Time frame: at 1 year after the procedure
length of postoperative hospital stay
Time frame: at discharge (within 10 days after the procedure)
hospitalization costs
Time frame: at discharge (within 10 days after the procedure)
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 9 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional Operating Room Echocardiography-guided ASD closure Group in people with ASD - Atrial Septal Defect, run by China National Center for Cardiovascular Diseases 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 3 inclusion and 4 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 9 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cheng Wang, MD,PhD (18610945896, zdwangcheng@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint events (time frame: at 30 days after the procedure). 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 9 Dec 2025.