A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
Starting soon · Phase 4
Conditions studied: Atrial Septal Defect (ASD)
In brief
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).
Key facts
- Study ID
- NCT07054541
- Run by
- Chinese Academy of Medical Sciences, Fuwai Hospital
- People needed
- 666
- Starts
- 2026-03-14
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-03-17
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
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：
- 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
Where it is running
- Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.