A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound-guided intervention with assistance of specialized instruments, fluoroscopy-guided intervention.
- Who it may be relevant to
- Registry conditions: Atrial Septal Defect (ASD). Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Procedure Ultrasound-guided intervention with assistance of specialized instruments
After detailed evaluation, patients will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments - Procedure fluoroscopy-guided intervention
After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process
Primary outcome measures
- Procedural success rate [Time frame: Immediately after implantation]
Secondary outcome measures (6)
- Successful closure rate [Time frame: Immediately after implantation, at 30 days, at 3 months after implantation]
- Composite of major adverse events [Time frame: At 3 months after implantation]
- Composite of minor adverse events [Time frame: At 3 months after implantation]
- Procedure time [Time frame: At discharge (assessed up to 3 months)]
- Days of hospital stay [Time frame: At discharge (assessed up to 3 months)]
- Hospitalization cost [Time frame: At discharge (assessed up to 3 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing
Identifiers
NCT: NCT07054541 · 2025-2614