A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire

NCT07054541 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-2614
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

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.In addition, patients with radiation contraindications or who refuse radiation therapy, and who are willing to undergo ultrasound-guided percutaneous atrial septal defect (ASD) closure with the assistance of dedicated devices, will be enrolled in a separate observational cohort (observational cohort study).

Conditions

Atrial Septal Defect (ASD)

Keywords

Ultrasound-guided; Percutaneous Intervention; Atrial Septal Defect; Pannawire; PAN Procedure; ASD closure; non fluoroscopic

Outcome Measures

Primary Outcomes (1)

• Procedural success rate

  Procedural success is defined as completion of the ASD closure without conversion to another guidance method or surgical repair under cardiopulmonary bypass, and with a residual shunt no greater than 2 mm immediately after implantation. Evaluation of the primary endpoint was done by specialized sonographers blinded to the intervention.

  Immediately after implantation

Secondary Outcomes (6)

• Successful closure rate

  Immediately after implantation, at 30 days, at 3 months after implantation

• Composite of major adverse events

  At 3 months after implantation

• Composite of minor adverse events

  At 3 months after implantation

• Procedure time

  At discharge (assessed up to 3 months)

• Days of hospital stay

  At discharge (assessed up to 3 months)

Study Arms (3)

Ultrasound-guided intervention with assistance of specialized instruments group

EXPERIMENTAL

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

Procedure: Ultrasound-guided intervention with assistance of specialized instruments

fluoroscopy-guided intervention group

ACTIVE COMPARATOR

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

Procedure: fluoroscopy-guided intervention

cohort

OTHER

Patients meet requirements but have contraindications to fluoroscopy, such as pregnancy, contrast allergy, malignancy, or thyroid dysfunction, are enrolled in the single-arm observational cohort to undergo echocardiography-guided ASD closure assistead by PannaWire

Procedure: Ultrasound-guided intervention with assistance of specialized instruments

Interventions

Ultrasound-guided intervention with assistance of specialized instruments PROCEDURE

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

Ultrasound-guided intervention with assistance of specialized instruments group; cohort

fluoroscopy-guided intervention PROCEDURE

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

fluoroscopy-guided intervention group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Cohort Eligibility 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
• Contraindications to radiation exposure or refusal to undergo fluoroscopy-guided procedures
• Associated cardiac malformations requiring surgical intervention
• Right-to-left shunt ASD

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

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

Study Officials

• Fengwen Zhang, MM

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengwen Zhang, MM

CONTACT

+8688396666; Zhangfengwen08@126.com

Ning Zhou

CONTACT

+8688396666; fwzhouning@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 8, 2025
• Study Start: March 14, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)