CliNical Study on UltrasOund-guided Percutaneous InterVention for AtriAl Septal Defect With the Assistance of Specialized Instruments (NOVA-ASD)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Atrial Septal Defect (ASD)

Treatments: Procedure: fluoroscopy-guided intervention; Procedure: Ultrasound-guided intervention with assistance of specialized instruments

Study type: Interventional

Funder types: Other

Identifiers

NCT07054541

2025-2614

Details and patient eligibility

About

Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. A retrospective analysis of over 20,000 adult patients with congenital heart disease revealed that even low-dose radiation exposure was significantly associated with an increased long-term risk of malignancy. Moreover, the use of contrast agents carries the risk of allergic reactions and kidney injury. Radiation and contrast agents not only pose iatrogenic harm to patients but also limit the use of interventional techniques in special populations, such as pregnant women, patients with contrast agent allergies, or those with renal insufficiency.

To achieve radiation-free and contrast-free interventional closure procedures, researchers have developed ultrasound-guided percutaneous interventional techniques, yielding satisfactory treatment outcomes. In some cases, these techniques have even enabled cardiovascular procedures to be performed on an outpatient basis, significantly reducing hospitalization time and costs.

This project proposes a large-sample, multicenter, prospective randomized controlled study to determine whether ultrasound-guided percutaneous intervention for ASD with the assistance of specialized instruments is non-inferior to traditional fluoroscopy-guided procedures, while also offering shorter hospital stays and lower medical expenses.

Enrollment: 666 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 2 years
• Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
• The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm

Exclusion criteria

• Pregnant women
• Contrast agent allergy
• Renal insufficiency
• Associated cardiac malformations requiring surgical intervention
• Right-to-left shunt ASD
• Ostium primum ASD and sinus venosus ASD
• Any severe infection within one month before the procedure
• Intracardiac thrombus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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666 participants in 2 patient groups

Ultrasound-guided intervention with assistance of specialized instruments group

Experimental group

Description:

Patients randomized in this group will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments.

Treatment:

Procedure: Ultrasound-guided intervention with assistance of specialized instruments

fluoroscopy-guided intervention group

Active Comparator group

Description:

Patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process

Treatment:

Procedure: fluoroscopy-guided intervention