Multicenter, randomized controlled study evaluating percutaneous and non-fluoroscopic procedure of atrial septal defects-study protocol of the PANASD randomized controlled trial.

BACKGROUND

Atrial septal defect (ASD) is one of the most common congenital heart diseases. Radiation exposure during transcatheter ASD closure poses cumulative risks for both patients and operators. We have pioneered a percutaneous and non-fluoroscopic procedure (PAN procedure) for a broad spectrum of cardiovascular interventional therapies, which eliminates the need for radiation and contrast. The PANASD trial is designed to compare PAN procedure with the traditional fluoroscopy procedure for transcatheter ASD closure. This article outlines the protocol of the study.

TRIAL

DESIGN

PANASD is a prospective, multicenter, randomized controlled trial enrolling approximately 660 patients for elective percutaneous ASD closure from eight participating centers in China. In this RCT, patients diagnosed with secundum ASD are randomized into two groups: one undergoing echocardiography-guided percutaneous ASD closure without the use of radiation and the other following the conventional fluoroscopy-guided procedure. The primary endpoint is the success rate of occlusion, defined as no conversion to surgery, a well-positioned occluder during hospitalization, and no major adverse events. Secondary endpoints include complication rates, costs, length of hospital stay, etc. Follow-up of the last enrolled patients will be completed in early 2026, and results will be available by late 2026. Data will be collected via an electronic data capture (EDC) system, and adverse events will be systematically recorded and monitored. Adherence to ethical principles, including informed consent and confidentiality, is maintained.

CONCLUSION

This RCT protocol represents the first clinical trial to compare the safety and efficacy of percutaneous and non-fluoroscopic ASD closure with the conventional fluoroscopic method.