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NCT Number: NCT07054541

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

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).

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Key information

Conditions

Atrial Septal Defect (ASD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location contact

Fengwen Zhang, MM

CONTACT

[email protected]

088396666

Fengwen Zhang, MM

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

RCT 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

Cohort 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
  • Contraindications to radiation exposure or refusal to undergo fluoroscopy-guided procedures

Exclusion criteria

  • 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

Treatment and study plan

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

fluoroscopy-guided intervention

Procedure

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

Primary outcomes

  1. Procedural success rate

    Time frame: Immediately after implantation

    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.

Secondary outcomes

  1. Successful closure rate

    Time frame: Immediately after implantation, at 30 days, at 3 months after implantation

    Residual shunt ≤ 2 mm immediately after implantation, at 30 days, at 3 months after implantation

  2. Composite of major adverse events

    Time frame: At 3 months after implantation

    Composite of major adverse events at 3 months, including sudden cardiac death, occluder displacement or dislodgement, pulmonary artery stenosis, descending aortic stenosis, pseudoaneurysm, bleeding requiring blood transfusion, new-onset hypertension, arrhythmia requiring pacemaker implantation or long-term medication, cardiac tamponade, stroke with sequelae.

  3. Composite of minor adverse events

    Time frame: At 3 months after implantation

    Composite of minor adverse events at 3 months, including groin hematoma, transient arrhythmia requiring medication or electrical cardioversion, perioperative allergic reaction, transient ischemic attack (TIA), anemia, postoperative infection.

  4. Procedure time

    Time frame: At discharge (assessed up to 3 months)

    Procedure time is defined as the duration from puncture to withdrawal of the arterial sheath

  5. Days of hospital stay

    Time frame: At discharge (assessed up to 3 months)

    Days of hospital stay

  6. Hospitalization cost

    Time frame: At discharge (assessed up to 3 months)

    cost during hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Fengwen Zhang, MM

CONTACT

[email protected]

+8688396666

Ning Zhou

CONTACT

[email protected]

+8688396666

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Acronym: PANNA-ASD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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