A scaffold-degradable single-rivet ASD occluder with amplatzer-like design: a multicenter randomized controlled trial.

Metallic atrial septal defect (ASD) occluders are associated with various mid- to long-term complications. To address this, our team developed a novel biodegradable Pansy ASD occluder, and this multicenter RCT aimed to evaluate its effectiveness and safety. A prospective, multicenter, randomized controlled trial was carried out on adult and pediatric patients using the Pansy occluder with a biodegradable polydioxanone (PDO) framework. The primary efficacy endpoint of this clinical trial is the closure success rate at six months post-operation. From May 2021 to March 2023, a total of 127 patients were screened across seven research centers, with 112 patients (including 71 pediatric patients; 57 to the experimental group, 55 to the metal occluder control group) ultimately underwent occluder implantation. In these patients, the average defect size was 8.48 ± 2.86 mm in the experimental group and 10.41 ± 5.21 mm in the control group. The closure success rate at six months post-operation was 100% for both groups, and no residual shunt greater than 5 mm was detected at any follow-up time point. In the experimental group, one patient required device explantation at 10 months postoperatively due to abnormal tissue hyperplasia. Pathological analysis confirmed near-complete degradation of the PDO framework with smooth endothelial coverage. A total of 109 patients completed the 12-month post-operative follow-up, with both groups again demonstrating a closure success rate of 100%. The Pansy occluder shows promising safety and efficacy outcomes at 12 months, though longer-term data are needed to confirm durability.