Reading basis: Based on the published JAMA article. This study concerns atrial septal defect (ASD), not patent foramen ovale (PFO).
What was actually studied?
The JAMA trial enrolled 230 participants with secundum ASD across 10 Chinese hospitals. It compared bioresorbable and metallic occluders, assessing closure at six months and following outcomes to two years. Xiangbin Pan is among the authors. [1]
- Who230 randomized participants with ASD
- ComparisonBioresorbable vs metallic device
- Design / endpointSix-month closure assessment
- ObservationFollow-up to two years
Original explanatory diagram based on source 1. This study concerns a different condition from PFO.
What did the investigators report?
The authors reported noninferiority for their six-month ASD closure endpoint and near-complete device degradation at two years. They found no statistically significant between-group difference in device-related adverse events at two years. The participants, endpoint and devices all belong to this ASD study. [1]
How to read the limits
The paper highlights limits in detecting rare events, the need for longer follow-up, and an untested potential benefit for future access across the atrial septum. Our interpretation: the findings do not establish lifetime equivalence or prove that rare events cannot occur. A result for ASD cannot simply be relabeled as a result for PFO. [1]
Why include it in a PFO-focused library?
We include the article to help readers distinguish related studies that can look similar in a search result. Before comparing a headline with your own situation, check the condition, device, participants and outcome being measured. Those details are more useful than the general phrase “bioresorbable occluder.”
- Does this study concern the condition my doctor diagnosed?
- Is there direct evidence for the device and procedure being proposed to me?
- Which details from this related study are relevant, and which are not?
Where to read the original
Ouyang W, Jiang H, Yan X, et al. Bioresorbable vs Metallic Occluders for Transcatheter Atrial Septal Defect Closure: A Randomized Clinical Trial. JAMA. 2025;334(19):1740–1749. DOI: 10.1001/jama.2025.17639.
Original publication ↗
This original reading note is prepared for the China Hospital Access website. It is not authored or endorsed by the researchers, and is not a reproduction of their publication. It provides general information, not an individual medical assessment.