Atrial Septal Defect (ASD)
Conditions
Keywords
Ultrasound-guided, Percutaneous Intervention, Atrial Septal Defect, Pannawire, PAN Procedure, ASD closure, non fluoroscopic
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).
Interventions
PROCEDUREUltrasound-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
PROCEDUREfluoroscopy-guided intervention
After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Successful closure rate | 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 |
| Composite of major adverse events | 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. |
| Composite of minor adverse events | 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. |
| Procedure time | At discharge (assessed up to 3 months) | Procedure time is defined as the duration from puncture to withdrawal of the arterial sheath |
| Days of hospital stay | At discharge (assessed up to 3 months) | Days of hospital stay |
| Hospitalization cost | At discharge (assessed up to 3 months) | cost during hospitalization |
Countries
China
Contacts
CONTACTFengwen Zhang, MM
CONTACTNing Zhou
PRINCIPAL_INVESTIGATORFengwen Zhang, MM
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed