Congenital heart diseaseRandomised controlled trial
Bioresorbable vs Metallic Occluders for Transcatheter Atrial Septal Defect Closure
- Randomised controlled trial
- multicentre
- non-inferiority
- open-label
- 10 hospital sites in China
Authors' conclusion
A bioresorbable occluder is noninferior to a metallic occluder for ASD closure, with near-complete degradation by 2 years.
Study context
- Population
- Participants with secundum atrial septal defect (ASD)229 implanted
- Participants
- 230 participants
- Comparison
- Bioresorbable vs metallic occluder for transcatheter ASD closure
- Bioresorbable occludern = 116
- Metallic occludern = 114reference
- Primary endpoint
- ASD closure success (procedural success with residual shunt ≤2 mm on transthoracic echocardiography)
- Follow-up
- 6 months
Primary result
As reported in the abstract
Between-group difference
−0.8 percentage points
95% CI −5.0 to 3.7
P < 0.001 for non-inferiority
Events by treatment group
Bioresorbable occluder vs Metallic occluder
between-group difference −0.8 percentage points (95% CI −5.0 to 3.7); P for non-inferiority < 0.001
Further findings
ASD closure success · 2 years
P = 0.75
- Degradation of bioresorbable occluder · 2 years
- 99.8%
Safety
Device-related adverse events · 2 years
P = 0.72
Original publication
Bioresorbable vs Metallic Occluders for Transcatheter Atrial Septal Defect Closure. JAMA. Published 23 October 2025. doi:10.1001/jama.2025.17639
Summarised from the published abstract; every number is checked against it