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

NCT07273227 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2024-2488
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ASD - Atrial Septal Defect

Keywords

echocardiography-guided; percutaneous intervention; atrial septal defect; mobile surgical vehicle; mobile surgical unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• failure of ultrasound-guided closure (conversion to fluoroscopy-guided intervention or open-heart surgery)

  immediately after the procedure

• residual shunt >2 mm

  at 30 days after the procedure

• device embolization or migration

  at 30 days after the procedure

• new-onset arrhythmia

  at 30 days after the procedure

• bleeding

  at 30 days after the procedure

Study Arms (2)

Mobile Surgical Vehicle Echocardiography-guided ASD closure Group

EXPERIMENTAL

Patients 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 Group

ACTIVE COMPARATOR

Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room.

Other: Conventional Operating Room Echocardiography-guided ASD closure Group

Interventions

Conventional Operating Room Echocardiography-guided ASD closure Group OTHER

Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed in a conventional operating room.

Conventional Operating Room Echocardiography-guided ASD closure Group

Mobile Surgical Vehicle Echocardiography-guided ASD closure Group OTHER

Patients undergo ultrasound-guided percutaneous atrial septal defect closure performed inside a mobile surgical vehicle.

Mobile Surgical Vehicle Echocardiography-guided ASD closure Group

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Cheng Wang, MD,PhD

CONTACT

18610945896; zdwangcheng@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 9, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

CN (1)