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

NCT ID: NCT07054541

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-10-31

Brief Summary

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.

Conditions

Atrial Septal Defect (ASD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound-guided intervention with assistance of specialized instruments group

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

Group Type: EXPERIMENTAL

Ultrasound-guided intervention with assistance of specialized instruments

Intervention Type: PROCEDURE

After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments

fluoroscopy-guided intervention group

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

Group Type: ACTIVE_COMPARATOR

fluoroscopy-guided intervention

Intervention Type: PROCEDURE

After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process

Interventions

Ultrasound-guided intervention with assistance of specialized instruments

After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments

Intervention Type: PROCEDURE

fluoroscopy-guided intervention

After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pan Xiangbin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fengwen Zhang, MM

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Fengwen Zhang, MM

Role: CONTACT

Zhangfengwen08@126.com

+8688396666

Ning Zhou

Role: CONTACT

fwzhouning@163.com

+8688396666

Facility Contacts

Fengwen Zhang, MM

Role: primary

Zhangfengwen08@126.com

088396666

Other Identifiers

2025-2614

Identifier Type: -

Identifier Source: org_study_id