A Multicenter Randomized Controlled Trial of Echocardiography-Guided Atrial Septal Defect Closure Performed in a Mobile Surgical Unit

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 Overview

• Status: Not yet recruiting
• Conditions: ASD - Atrial Septal Defect
• Intervention / Treatment: Other: Mobile Surgical Vehicle Echocardiography-guided ASD closure Group; Other: Conventional Operating Room Echocardiography-guided ASD closure Group

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cheng Wang, MD,PhD; Phone Number: 18610945896; Email: zdwangcheng@outlook.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
      • Contact: Cheng Wang, MD.PhD; Phone Number: 18610945896; Email: zdwangcheng@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Surgical Vehicle Echocardiography-guided ASD closure Group; Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed inside a mobile surgical vehicle.	Other: Mobile Surgical Vehicle Echocardiography-guided ASD closure Group; Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed inside a mobile surgical vehicle.
Active Comparator: Conventional Operating Room Echocardiography-guided ASD closure Group; Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room.	Other: Conventional Operating Room Echocardiography-guided ASD closure Group; Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 30 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	immediately after the procedure
residual shunt >2 mm	residual shunt >2 mm under echocardiography	at 30 days after the procedure
device embolization or migration	new device embolization or migration after procedure	at 30 days after the procedure
new-onset arrhythmia	new-onset arrhythmia after procedure	at 30 days after the procedure
bleeding	new bleeding after the procedure	at 30 days after the procedure
infection	new infection after procedure	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.	at 1 year after the procedure
length of postoperative hospital stay	length of postoperative hospital stay	at discharge (within 10 days after the procedure)
hospitalization costs	hospitalization cost	at discharge (within 10 days after the procedure)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): December 19, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: atrial septal defect; percutaneous intervention; echocardiography-guided; mobile surgical vehicle; mobile surgical unit
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects, Atrial
• Other Study ID Numbers: 2024-2488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No