Trial reportCardiovascular intervention and therapeutics2026
A scaffold-degradable single-rivet ASD occluder with amplatzer-like design: a multicenter randomized controlled trial.
Trial report in Cardiovascular intervention and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
16 authors.
Funding
Abstract
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.
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